Pre-connected analyte sensors

ABSTRACT

Pre-connected analyte sensors are provided. A pre-connected analyte sensor includes a sensor carrier attached to an analyte sensor. The sensor carrier includes a substrate configured for mechanical coupling of the sensor to testing, calibration, or wearable equipment. The sensor carrier also includes conductive contacts for electrically coupling sensor electrodes to the testing, calibration, or wearable equipment.

INCORPORATION BY REFERENCE TO RELATED APPLICATIONS

Any and all priority claims identified in the Application Data Sheet, orany correction thereto, are hereby incorporated by reference under 37CFR 1.57. This application is a continuation of U.S. application Ser.No. 17/464,547, filed on Sep. 1, 2021, which is a continuation of U.S.application Ser. No. 17/369,535, filed on Jul. 7, 2021, now U.S. Pat.No. 11,160,926, which is a continuation of U.S. patent application Ser.No. 16/167,976, filed on Oct. 23, 2018, which claims the benefit of U.S.Provisional Application No. 62/576,560, filed on Oct. 24, 2017. Theaforementioned application is incorporated by reference herein in itsentirety, and each is hereby expressly made a part of thisspecification.

TECHNICAL FIELD

The present disclosure generally relates to sensors and, moreparticularly, to analyte sensors such as continuous analyte sensors.

BACKGROUND

Diabetes mellitus is a disorder in which the pancreas cannot createsufficient insulin (Type I or insulin dependent) and/or in which insulinis not effective (Type 2 or non-insulin dependent). In the diabeticstate, the victim suffers from high blood sugar, which can cause anarray of physiological derangements associated with the deterioration ofsmall blood vessels, for example, kidney failure, skin ulcers, orbleeding into the vitreous of the eye. A hypoglycemic reaction (lowblood sugar) can be induced by an inadvertent overdose of insulin, orafter a normal dose of insulin or glucose-lowering agent accompanied byextraordinary exercise or insufficient food intake.

Conventionally, a person with diabetes carries a self-monitoring bloodglucose (SMBG) monitor, which typically requires uncomfortable fingerpricking methods. Due to the lack of comfort and convenience, a personwith diabetes normally only measures his or her glucose levels two tofour times per day. Unfortunately, such time intervals are spread so farapart that the person with diabetes likely finds out too late of ahyperglycemic or hypoglycemic condition, sometimes incurring dangerousside effects. Glucose levels may be alternatively monitored continuouslyby a sensor system including an on-skin sensor assembly. The sensorsystem may have a wireless transmitter which transmits measurement datato a receiver which can process and display information based on themeasurements.

This Background is provided to introduce a brief context for the Summaryand Detailed Description that follow. This Background is not intended tobe an aid in determining the scope of the claimed subject matter nor beviewed as limiting the claimed subject matter to implementations thatsolve any or all of the disadvantages or problems presented above.

SUMMARY

There are various steps in the manufacturing process of an analytesensor such as a continuous analyte sensor for which temporarymechanical and electrical connections between the sensor andmanufacturing equipment such as testing and/or calibration equipment areused. These connections are facilitated by accurate placement andalignment of the sensor to mechanical and electrical interfaces of thetesting and/or calibration equipment. A device such as an“interconnect”, “interposer” or “sensor carrier” can be attached to anelongated body of the sensor, as described hereinafter, to assist withhandling, and both temporary and permanent, electrical and mechanicalconnections. A sensor carrier (also referred to as a “sensorinterposer”) may also include features for tracking, data storage, andsealing sensor electrodes, from each other and from the environment.Without limiting the scope of the present embodiments as expressed bythe claims that follow, their more prominent features now will bediscussed briefly. After considering this discussion, and particularlyafter reading the section entitled “Detailed Description,” one willunderstand how the features of the present embodiments provide theadvantages described herein.

In accordance with a first aspect, a method of manufacturing a sensor isprovided. The method includes providing an analyte sensor having anelongated body, a first electrode, a second electrode coaxially locatedwithin the first electrode, and at least two electrical contactslongitudinally aligned and spaced along a longitudinal axis of thesensor. The method includes attaching a sensor carrier to the analytesensor, the sensor carrier including an intermediate body, a firstconductive portion disposed on the intermediate body, the firstconductive portion in electrical communication with the first electrode,a second conductive portion disposed on the intermediate body, thesecond conductive portion in electrical communication with the secondelectrode. The first and second conductive portions form a connectionportion configured to establish electrical connection between the sensorand a separate device.

In a generally applicable embodiment (i.e. independently combinable withany of the aspects or embodiments identified herein) of the firstaspect, the method further includes coupling an outer layer to theintermediate body. The outer layer includes an identifier. The outerlayer, the sensor, and the intermediate body can form a laminatedconfiguration. The identifier can be a QR code sheet. The identifier caninclude any of an optical identifier, a radio-frequency identifier, or amemory-encoded identifier. The identifier can identify the analytesensor, calibration data for the analyte sensor, or a history of theanalyte sensor.

In a generally applicable embodiment (i.e. independently combinable withany of the aspects or embodiments identified herein) of the firstaspect, the method further includes coating the sensor with a membraneafter attaching the sensor to the sensor carrier.

In a generally applicable embodiment (i.e. independently combinable withany of the aspects or embodiments identified herein) of the firstaspect, the first conductive portion and the second conductive portionare traces. The traces can extend from a distal position of the sensorcarrier and terminate at a proximal end of the sensor carrier. Thetraces can form exposed contact surfaces in the connection portion. Thefirst and second conductive portions can be embedded into theintermediate body.

In a generally applicable embodiment (i.e. independently combinable withany of the aspects or embodiments identified herein) of the firstaspect, the first conductive portion and the second conductive portionare solder welds. The solder welds can attach the sensor to the sensorcarrier.

In a generally applicable embodiment (i.e. independently combinable withany of the aspects or embodiments identified herein) of the firstaspect, the first conductive portion and the second conductive portionare conductive tapes. The conductive tapes can attach the sensor to thesensor carrier.

In a generally applicable embodiment (i.e. independently combinable withany of the aspects or embodiments identified herein) of the firstaspect, the connection portion is configured to mechanically mate withthe separate device.

In a generally applicable embodiment (i.e. independently combinable withany of the aspects or embodiments identified herein) of the firstaspect, the separate device is an electronics unit configured to measureanalyte data.

In a generally applicable embodiment (i.e. independently combinable withany of the aspects or embodiments identified herein) of the firstaspect, the separate device is a component of a manufacturing station.The method can further include performing at least one of a potentiostatmeasurement, a dipping process, a curing process, a calibration process,or a sensitivity measurement while the electrical connection isestablished between the sensor and the manufacturing station. The methodcan further include de-establishing electrical connection between thesensor and the calibration station. The method can further includeestablishing electrical connection between the sensor and at least onetesting station via the connection portion of the sensor carrier.

In a generally applicable embodiment (i.e. independently combinable withany of the aspects or embodiments identified herein) of the firstaspect, the intermediate body further includes a datum structure thatcontrols a position and spatial orientation of the analyte sensorrelative to a substrate of the intermediate body. The datum structurecan include a flexible portion of the substrate that is folded over atleast a portion of the analyte sensor.

In a generally applicable embodiment (i.e. independently combinable withany of the aspects or embodiments identified herein) of the firstaspect, the first conductive portion and/or the second conductiveportion comprise at least one of a coil spring, a leaf spring, or aconductive elastomer.

In accordance with a second aspect, an apparatus is provided thatincludes an analyte sensor having an elongated body, a first electrodein electrical communication with a first conductive contact, a secondelectrode in electrical communication with a second conductive contact.The sensor carrier can be attached to the analyte sensor. The sensorcarrier can include an intermediate body, a first conductive portiondisposed on the intermediate body, the first conductive portion inelectrical communication with the first conductive contact, and a secondconductive portion disposed on the intermediate body, the secondconductive portion in electrical communication with the secondconductive contact. The first and second conductive portions can form aconnection portion configured to establish electrical communicationbetween the first and second conductive contacts and a separate device.

In a generally applicable embodiment (i.e. independently combinable withany of the aspects or embodiments identified herein) of the secondaspect, the apparatus further includes an identifier coupled to theintermediate body. The identifier, the sensor, and the intermediate bodycan form a laminated configuration. The identifier can be a QR codesheet. The identifier can be any of an optical identifier, aradio-frequency identifier, or a memory-encoded identifier. Theidentifier can be configured to identify any of the analyte sensor,calibration data for the analyte sensor, and a history of the analytesensor.

In a generally applicable embodiment (i.e. independently combinable withany of the aspects or embodiments identified herein) of the secondaspect, the first conductive portion and the second conductive portionare traces. The traces can form exposed contact surfaces in theconnection portion. The first and second conductive portions can be atleast partially embedded into the intermediate body.

In a generally applicable embodiment (i.e. independently combinable withany of the aspects or embodiments identified herein) of the secondaspect, the first conductive portion and the second conductive portioninclude at least one of a solder weld, a conductive tape, a coil spring,a leaf spring, or a conductive elastomer.

In a generally applicable embodiment (i.e. independently combinable withany of the aspects or embodiments identified herein) of the secondaspect, the connection portion is configured to mechanically mate withthe separate device.

In a generally applicable embodiment (i.e. independently combinable withany of the aspects or embodiments identified herein) of the secondaspect, the separate device is an electronics unit configured to measureanalyte data.

In a generally applicable embodiment (i.e. independently combinable withany of the aspects or embodiments identified herein) of the secondaspect, the separate device is a component of a manufacturing station.At least one of a potentiostat measurement, a dipping process, a curingprocess, a calibration process, or a sensitivity measurement can beconfigured to be performed while the electrical connection isestablished between the sensor and the manufacturing station. Themanufacturing station can comprise a calibration station configured tode-establish electrical connection between the sensor and thecalibration station and establish electrical connection between thesensor and at least one testing station via the connection portion ofthe sensor carrier.

In a generally applicable embodiment (i.e. independently combinable withany of the aspects or embodiments identified herein) of the secondaspect, the intermediate body further comprises a datum structureconfigured to control a position and spatial orientation of the analytesensor relative to a substrate of the intermediate body.

In a generally applicable embodiment (i.e. independently combinable withany of the aspects or embodiments identified herein) of the secondaspect, the first electrode may be positioned coaxially within thesecond electrode, and the first electrical contact and the secondelectrical contact may be longitudinally aligned and spaced along alongitudinal axis of the sensor.

In a generally applicable embodiment (i.e. independently combinable withany of the aspects or embodiments identified herein) of the secondaspect, the first electrode and the second electrode may be affixed to aflexible planar substrate. In addition, the first electrical contact andthe second electrical contact may be affixed to the flexible planarsubstrate.

In a generally applicable embodiment (i.e. independently combinable withany of the aspects or embodiments identified herein) of the secondaspect, the first conductive contact and the second conductive contactare affixed to the intermediate body with conductive adhesive.

In a generally applicable embodiment (i.e. independently combinable withany of the aspects or embodiments identified herein) of the secondaspect, the first conductive contact and the second conductive contactare affixed to the intermediate body with anisotropic conductive film.

In accordance with a third aspect, an array of pre-connected analytesensors is provided. The array includes a substrate, a first pluralityof electrical contacts disposed on the substrate, a second plurality ofelectrical contacts disposed on the substrate, and a plurality ofanalyte sensors disposed on the substrate. Each of the plurality ofanalyte sensors includes a first sensor electrical contact coupled to acorresponding one of the first plurality of electrical contacts on thesubstrate, and a second sensor electrical contact coupled to acorresponding one of the second plurality of electrical contacts on thesubstrate. The array may comprise one or more strips.

In a generally applicable embodiment (i.e. independently combinable withany of the aspects or embodiments identified herein) of the thirdaspect, the first plurality of electrical contacts are aligned along thesubstrate. The first plurality of electrical contacts can be formed froman exposed contact surface.

In a generally applicable embodiment (i.e. independently combinable withany of the aspects or embodiments identified herein) of the thirdaspect, the second plurality of electrical contacts are aligned alongthe substrate. The second plurality of electrical contacts can be formedfrom an exposed contact surface.

In a generally applicable embodiment (i.e. independently combinable withany of the aspects or embodiments identified herein) of the thirdaspect, the first and second plurality of electrical contacts areconfigured to connect with a separate device. The separate device can bea component of a manufacturing station.

In a generally applicable embodiment (i.e. independently combinable withany of the aspects or embodiments identified herein) of the thirdaspect, the substrate includes at least one singulation featureconfigured to facilitate singulation of the substrate into a pluralityof sensor carriers, wherein each of the plurality of sensor carriers isattached to a corresponding one of the analyte sensors.

In a generally applicable embodiment (i.e. independently combinable withany of the aspects or embodiments identified herein) of the thirdaspect, the strip further includes a plurality of identifiers disposedon the substrate.

In a generally applicable embodiment (i.e. independently combinable withany of the aspects or embodiments identified herein) of the thirdaspect, the substrate includes an elongated dimension, wherein theplurality of analyte sensors extend beyond an edge of the substrate in adirection orthogonal to the elongated dimension. The strip can furtherinclude a feed-guide strip that runs along an opposing edge of thesubstrate in the elongated dimension. The substrate can further includea flexible substrate configured to be rolled onto a reel. The feed-guidestrip can be removable from the substrate.

In a generally applicable embodiment (i.e. independently combinable withany of the aspects or embodiments identified herein) of the thirdaspect, the substrate comprises a molded thermoplastic having aplurality of datum features that control a position and orientation ofthe plurality of analyte sensors, and wherein the a first plurality ofelectrical contacts and the second plurality of electrical contacts eachcomprise embedded conductive traces in the molded thermoplastic.

In a generally applicable embodiment (i.e. independently combinable withany of the aspects or embodiments identified herein) of the thirdaspect, the strip further includes a first datum structure coupled tothe strip, the first datum structure configured to position theplurality of analyte sensors. The first datum structure includes atleast one singulation feature configured to facilitate singulation ofthe first datum structure into a plurality of second datum structures,wherein each of the plurality of second datum structures is coupled to acorresponding one of a plurality of sensor carriers formed by thesubstrate.

In a generally applicable embodiment (i.e. independently combinable withany of the aspects or embodiments identified herein) of the thirdaspect, the strip further includes a carrier having processing circuitryconfigured to perform at least potentiostat measurements for theplurality of analyte sensors. The strip can further includecommunications circuitry operable by the processing circuitry to sendand receive data associated with each of the analyte sensors togetherwith an identifier for that analyte sensor.

In accordance with a fourth aspect, a method is provided. The methodincludes providing a pre-connected analyte sensor, the pre-connectedanalyte sensor comprising an intermediate body, an analyte sensorpermanently attached to the intermediate body, and an identifier coupledto the intermediate body. The method includes communicatively couplingthe analyte sensor to a processing circuitry of a manufacturing stationby coupling the intermediate body to a corresponding feature of themanufacturing station. The method includes operating the processingcircuitry of the manufacturing station to communicate with thepre-connected analyte sensor.

In a generally applicable embodiment (i.e. independently combinable withany of the aspects or embodiments identified herein) of the fourthaspect, operating the processing circuitry includes obtaining a signalfrom the analyte sensor via the connection portion. Operating theprocessing circuitry can include operating an optical, infrared, orradio-frequency reader of the manufacturing station to obtain theidentifier.

In a generally applicable embodiment (i.e. independently combinable withany of the aspects or embodiments identified herein) of the fourthaspect, the method further includes storing, with the processingcircuitry of the manufacturing station and in connection with theidentifier, sensor data corresponding to the signal. The identifier canidentify any of the analyte sensor, calibration data for the analytesensor, and a history of the analyte sensor.

In a generally applicable embodiment (i.e. independently combinable withany of the aspects or embodiments identified herein) of the fourthaspect, the signal includes a glucose sensitivity signal.

In a generally applicable embodiment (i.e. independently combinable withany of the aspects or embodiments identified herein) of the fourthaspect, the method further includes removing the pre-connected analytesensor from the manufacturing station and communicatively coupling theanalyte sensor to processing circuitry of a wearable device bymechanically coupling an anchoring feature of the intermediate body to acorresponding feature of a wearable device. The method can furtherinclude obtaining in vivo measurement data from the analyte sensor withthe processing circuitry of the wearable device.

In a generally applicable embodiment (i.e. independently combinable withany of the aspects or embodiments identified herein) of the fourthaspect, the analyte sensor is permanently attached to the intermediatebody with conductive adhesive.

In a generally applicable embodiment (i.e. independently combinable withany of the aspects or embodiments identified herein) of the fourthaspect, the analyte sensor is permanently attached to the intermediatebody with anisotropic conductive film.

In accordance with a fifth aspect, a wearable device is provided. Thewearable device comprises a housing and electronic circuitry configuredto process analyte sensor signals. The electronic circuitry is enclosedwithin the housing. An analyte sensor has a distal portion positionedoutside the housing. An intermediate body has an electrical connectionto both a proximal portion of the analyte sensor and the electronics,wherein the electrical connection between the intermediate body and theproximal portion of the analyte sensor is external to the housing.

In generally applicable embodiments (i.e. independently combinable withany of the aspects or embodiments identified herein) of the fifth aspectthe intermediate body may be positioned adjacent to an exterior surfaceof the housing. The device may include electrical contacts coupled toboth the electronics and the intermediate body. The intermediate bodymay be electrically connected to the electrical contacts with conductiveepoxy. The intermediate body is electrically connected to the electricalcontacts with anisotropic conductive film. The intermediate body may besealed. The electrical contacts may extend through the housing. Theintermediate body may be positioned in a recess on the exterior surfaceof the housing. The electrical contacts may extend through the housingin the recess to electrically couple the intermediate body to theelectronic circuitry enclosed within the housing. The intermediate bodymay be covered with a polymer in the recess.

In generally applicable embodiments (i.e. independently combinable withany of the aspects or embodiments identified herein) of the fifth aspectthe analyte sensor is formed as an elongated body with a distal portionconfigured for percutaneous implantation in a subject and a proximalportion configured for electrically connecting to the intermediate body.The distal portion of the analyte sensor may extend away from an openingthrough the housing. The electronic circuitry may comprise apotentiostat and/or a wireless transmitter.

In accordance with a sixth aspect, a method of making a pre-connectedanalyte sensor is provided. The method comprises mechanically andelectrically connecting a proximal portion of an elongated conductor toa conductive portion of an intermediate body, and after the connecting,coating a distal portion of the elongated conductor with a polymermembrane to form an analyte sensor having a working electrode regionconfigured to support electrochemical reactions for analyte detection inthe distal portion of the elongated conductor.

In generally applicable embodiments (i.e. independently combinable withany of the aspects or embodiments identified herein) of the sixthaspect, the method additionally comprises testing the analyte sensor,wherein the testing comprises electrically coupling the intermediatebody to a testing station. The method may additionally comprisecalibrating the analyte sensor, wherein the calibrating compriseselectrically coupling the intermediate body to a testing station. Thecoating may comprise dip coating.

In generally applicable embodiments (i.e. independently combinable withany of the aspects or embodiments identified herein) of the sixthaspect, the intermediate body may be part of an array formed by aplurality of coupled intermediate bodies, wherein the method furthercomprises mechanically and electrically connecting a proximal portion ofeach of a plurality of elongated electrodes to a conductive portion ofeach intermediate body of the array. The coating may be performed inparallel on each distal portion of each of the plurality of elongatedelectrodes connected to the intermediate bodies of the array. The methodmay comprise singulating one or more of the intermediate bodies of thearray after the coating.

In generally applicable embodiments (i.e. independently combinable withany of the aspects or embodiments identified herein) of the sixthaspect, mechanically and electrically connecting comprises applyingconductive paste to the elongated conductor and the conductive portionof the intermediate body. In some embodiments, mechanically andelectrically connecting comprises compressing anisotropic conductivefilm between the proximal portion of the elongated conductor and theconductive portion of the intermediate body. The connecting may beperformed at a location remote from the coating. In some embodiments,the coating, testing, and calibrating are all performed at a locationremote from the connecting.

In accordance with a seventh aspect, a method of making an on-skinwearable percutaneous analyte sensor comprises assembling electroniccircuitry into an internal volume of a housing, wherein the electroniccircuitry is configured for (1) detecting signals generated from anelectrochemical reaction under the skin of a subject at a workingelectrode of an analyte sensor, and (2) wirelessly transmitting dataderived from the detected signals outside of the housing for processingand/or display by a separate device. After assembling the electroniccircuitry into the internal volume of the housing, attaching a proximalportion of the analyte sensor to an external electrical interfacecoupled to the electronic circuitry such that the electronic circuitrybecomes connected to the analyte sensor to receive signals therefromwithout opening the housing.

In generally applicable embodiments (i.e. independently combinable withany of the aspects or embodiments identified herein) of the seventhaspect, the method comprises sealing the interface after attaching theproximal portion of the analyte sensor. The method may comprise testingthe electronic circuitry for functionality prior to the attaching. Themethod may comprise testing the analyte sensor for functionality priorto the attaching. The assembling may be performed at a location remotefrom the attaching.

In generally applicable embodiments (i.e. independently combinable withany of the aspects or embodiments identified herein) of the seventhaspect, the method may comprise coupling an intermediate body to theproximal portion of the analyte sensor, and the attaching may compriseattaching the intermediate body to the external electrical interface.The method may then comprise performing at least one manufacturing ortesting procedure on the working electrode using the intermediate bodyprior to the attaching. The performing may comprise coating the workingelectrode of the analyte sensor. The coupling may be performed at afirst location, the assembling may be performed at a second location,and the performing may be performed at a third location, wherein thefirst, second, and third locations are remote from one another. Theattaching and/or the coupling may be performed with anisotropicconductive film The method may further comprise attaching an inserter tothe housing for implanting the working electrode into a subject.

It is understood that various configurations of the subject technologywill become readily apparent to those skilled in the art from thedisclosure, wherein various configurations of the subject technology areshown and described by way of illustration. As will be realized, thesubject technology is capable of other and different configurations andits several details are capable of modification in various otherrespects, all without departing from the scope of the subjecttechnology. Accordingly, the summary, drawings and detailed descriptionare to be regarded as illustrative in nature and not as restrictive.

BRIEF DESCRIPTION OF THE DRAWINGS

The present embodiments now will be discussed in detail with an emphasison highlighting the advantageous features. These embodiments are forillustrative purposes only and are not to scale, instead emphasizing theprinciples of the disclosure. These drawings include the followingfigures, in which like numerals indicate like parts:

FIG. 1 is a schematic view of an analyte sensor system attached to ahost and communicating with a plurality of example devices, according tosome embodiments.

FIG. 2 is a block diagram that illustrates electronics associated withthe sensor system of FIG. 1 , according to some embodiments.

FIGS. 3A-3C illustrate a wearable device having an analyte sensor,according to some embodiments.

FIG. 3D illustrates one implementation of an elongated sensor connectedto a potentiostat.

FIG. 4A illustrates a schematic of a pre-connected analyte sensor,according to some embodiments.

FIG. 4B illustrates another schematic of a pre-connected analyte sensor,according to some embodiments.

FIG. 4C illustrates a layered view of a pre-connected analyte sensor,according to some embodiments.

FIG. 4D illustrates a schematic view of an array of pre-connectedanalyte sensors, according to some embodiments.

FIGS. 5A-5E illustrate block diagrams of a system having a manufacturingsystem and a wearable device for an analyte sensor, according to someembodiments.

FIG. 6 illustrates a cross-sectional schematic view of a wearable devicewith a pre-connected analyte sensor, according to some embodiments.

FIG. 7 illustrates a cross-sectional schematic view of a wearable devicewith a pre-connected analyte sensor, according to some embodiments.

FIG. 8 illustrates a cross-sectional schematic view of a wearable devicewith a pre-connected analyte sensor, according to some embodiments.

FIG. 9 illustrates a perspective view of an on-skin sensor assembly,according to some embodiments.

FIGS. 10 and 11 illustrate perspective views of sensor carriers thathave springs, according to some embodiments.

FIG. 12 illustrates a cross-sectional perspective view of a portion of asensor carrier, according to some embodiments.

FIGS. 13A-13B illustrate perspective views of a wearable sensorassembly, according to some embodiments.

FIG. 13C illustrates an exploded view of components of a wearable sensorassembly, according to some embodiments.

FIGS. 14A-14B illustrate perspective views of another wearable sensorassembly, according to some embodiments.

FIG. 14C illustrates an exploded view of components of another wearablesensor assembly, according to some embodiments, including an externalelectrical interface embodiment.

FIG. 14D illustrates a top plan view of the external electricalinterface of FIG. 14C with a pre-connected sensor assembly installed.

FIG. 14E is a cross section along lines E-E in FIG. 14D.

FIG. 15A illustrates another embodiment of a printed circuit boardsubstrate for a sensor carrier.

FIGS. 15B and 15C illustrate alternative embodiments for coupling asensor and sensor carrier to an electrical interface of a wearablesensor assembly.

FIG. 16 illustrates a top view of a sensor carrier attached to ananalyte sensor with conductive adhesive, according to some embodiments.

FIG. 17 illustrates an end view of a sensor carrier attached to ananalyte sensor with conductive adhesive, according to some embodiments.

FIG. 18 illustrates an end view of a sensor carrier attached to ananalyte sensor with conductive adhesive in a recess of a sensor carriersubstrate, according to some embodiments.

FIG. 19 illustrates an end view of a sensor carrier attached to ananalyte sensor with conductive adhesive in a corner of a sensor carriersubstrate, according to some embodiments.

FIG. 20 illustrates an end view of a sensor carrier attached to ananalyte sensor with conductive adhesive in a rounded recess of a sensorcarrier substrate, according to some embodiments.

FIGS. 21A and 21B illustrate a perspective view and an end viewrespectively of an analyte sensor attached to a sensor carrier in guidestructures.

FIG. 22 illustrates a top view of a sensor carrier attached to ananalyte sensor with conductive tape, according to some embodiments.

FIG. 23 illustrates a top view of a sensor carrier having a substrateattached to and wrapped around an analyte sensor, according to someembodiments.

FIG. 24 illustrates a top view of a sensor carrier attached to ananalyte sensor with welded conductive plastic, according to someembodiments.

FIGS. 25 and 26 illustrate manufacturing equipment for attaching asensor carrier to an analyte sensor with conductive plastic, accordingto some embodiments.

FIG. 27 is a perspective-view schematic illustrating a proximal portionof an analyte sensor having flattened electrical connector portions,according to some embodiments.

FIG. 28 illustrates a side view of the analyte sensor of FIG. 24attached to a sensor carrier, according to some embodiments.

FIG. 29 illustrates a top view of a sensor carrier having a flexiblesubstrate configured to wrap around an analyte sensor, according to someembodiments.

FIG. 30 illustrates a perspective view of a sensor carrier havingsubstrate with a flexible portion configured to wrap around an analytesensor, according to some embodiments.

FIGS. 31A and 31B illustrate another embodiment of a sensor carrierattached to an analyte sensor.

FIG. 32 illustrates a top view of a sensor carrier having a movablefastener for attaching an analyte sensor, according to some embodiments.

FIG. 33 illustrates a perspective view of the movable fastener of FIG.29 , according to some embodiments.

FIG. 34 illustrates a perspective view of a sensor carrier implementedas a barrel fastener, according to some embodiments.

FIG. 35A illustrates a face-on view of a sensor carrier having aflexible substrate wrapped around an analyte sensor, according to someembodiments.

FIG. 35B illustrates a perspective view of a sensor carrier having aflexible substrate wrapped around multiple analyte sensors, according tosome embodiments.

FIG. 36 illustrates an end view of a sensor carrier having a crimpconnector, according to some embodiments.

FIG. 37 illustrates an end view of a sensor carrier attached to ananalyte sensor by a crimp connector, according to some embodiments.

FIG. 38 illustrates a side view of a sensor carrier having crimpconnectors, according to some embodiments.

FIG. 39 illustrates a perspective view of a sensor carrier, according tosome embodiments.

FIG. 40 illustrates a perspective view of a sensor carrier formed from amolded interconnect device, according to some embodiments.

FIG. 41 illustrates a top view of a sensor carrier formed from a moldedinterconnect device, according to some embodiments.

FIG. 42 illustrates a side view of a sensor carrier attached to ananalyte sensor by a conductive coupler, according to some embodiments.

FIG. 43 illustrates a side view of a sensor carrier having an elongateddimension for attachment to multiple analyte sensors, according to someembodiments.

FIG. 44 illustrates a top view of a sensor carrier having a flexiblesubstrate for wrapping around an analyte sensor, according to someembodiments.

FIG. 45 illustrates a top view of another sensor carrier having aflexible substrate for wrapping around an analyte sensor, according tosome embodiments.

FIG. 46 illustrates a top view of another sensor carrier having aflexible substrate for wrapping around an analyte sensor, according tosome embodiments.

FIG. 47A illustrates a side view of a sensor carrier having a feed-guidestrip on an elongated dimension for attachment to multiple analytesensors, according to some embodiments.

FIG. 47B illustrates a perspective view of the sensor carrier of FIG.47A wrapped on a reel, according to some embodiments.

FIG. 48 illustrates a top view of the sensor carrier of FIG. 47A with asensor carrier singulated from the sensor carrier, according to someembodiments.

FIG. 49 illustrates a perspective view of a sensor carrier havingspring-loaded receptacles for attachment of multiple analyte sensors,according to some embodiments.

FIG. 50 illustrates a perspective view of a sensor carrier havingmagnetic datum features for positioning and orientation of multipleanalyte sensors, according to some embodiments.

FIG. 51A illustrates a top view of a sensor carrier having a rigid flexpanel for attachment to multiple analyte sensors, according to someembodiments.

FIG. 51B illustrates a top view of a sensor carrier having a rigid flexpanel for attachment to multiple analyte sensors having an edge cardconnector pad for electronic connection, according to some embodiments.

FIG. 52A illustrates a top view of a sensor carrier singulated from thesensor carrier of FIG. 48 and attached to an analyte sensor to form apre-connected sensor, according to some embodiments.

FIG. 52B illustrates a sensor carrier having a rigid flex panel forattachment to multiple analyte sensors of FIG. 48B without the V-scoreportion, according to some embodiments.

FIG. 53A illustrates the pre-connected sensor to be installed in awearable device, according to some embodiments.

FIG. 53B illustrates the pre-connected sensor in a folded position to beinstalled in a wearable device, according to some embodiments.

FIG. 54 illustrates a sensor carrier implemented as a daughter board forconnection to an analyte sensor, according to some embodiments.

FIG. 55 illustrates a sensor carrier implemented with a pinch clip,according to some embodiments.

FIG. 56 illustrates a sensor carrier having clips for connection to ananalyte sensor, according to some embodiments.

FIG. 57 is a flow chart of illustrative operations that may be performedfor manufacturing and using a pre-connected sensor, according to someembodiments.

FIG. 58 illustrates a perspective view of a sensor-holding apparatushaving a fluted flexible tube, according to some embodiments

FIG. 59 illustrates an exploded perspective view of the apparatus ofFIG. 58 , according to some embodiments.

FIG. 60 illustrates a device that includes a sensor mounted in theapparatus of FIG. 55 , according to some embodiments.

FIG. 61 illustrates a diagram of a carrier for pre-connected sensors,according to some embodiments.

Like reference numerals refer to like elements throughout. Elements arenot to scale unless otherwise noted.

DETAILED DESCRIPTION

The following description and examples illustrate some exemplaryimplementations, embodiments, and arrangements of the disclosedinvention in detail. Those of skill in the art will recognize that thereare numerous variations and modifications of this invention that areencompassed by its scope. Accordingly, the description of a certainexample embodiment should not be deemed to limit the scope of thepresent invention.

Definitions

In order to facilitate an understanding of the various embodimentsdescribed herein, a number of terms are defined below.

The term “analyte” as used herein is a broad term and is to be given itsordinary and customary meaning to a person of ordinary skill in the art(and is not to be limited to a special or customized meaning), andfurthermore refers without limitation to a substance or chemicalconstituent in a biological fluid (for example, blood, interstitialfluid, cerebral spinal fluid, lymph fluid or urine) that can beanalyzed. Analytes can include naturally occurring substances,artificial substances, metabolites, and/or reaction products. In someembodiments, the analyte for measurement by the sensor heads, devices,and methods is analyte. However, other analytes are contemplated aswell, including but not limited to acarboxyprothrombin; acylcarnitine;adenine phosphoribosyl transferase; adenosine deaminase; albumin;alpha-fetoprotein; amino acid profiles (arginine (Krebs cycle),histidine/urocanic acid, homocysteine, phenylalanine/tyrosine,tryptophan); andrenostenedione; antipyrine; arabinitol enantiomers;arginase; benzoylecgonine (cocaine); biotinidase; biopterin; c-reactiveprotein; carnitine; carnosinase; CD4; ceruloplasmin; chenodeoxycholicacid; chloroquine; cholesterol; cholinesterase; conjugated 1-βhydroxy-cholic acid; cortisol; creatine kinase; creatine kinase MMisoenzyme; cyclosporin A; D-penicillamine; de-ethylchloroquine;dehydroepiandrosterone sulfate; DNA (acetylator polymorphism, alcoholdehydrogenase, alpha 1-antitrypsin, cystic fibrosis, Duchenne/Beckermuscular dystrophy, analyte-6-phosphate dehydrogenase, hemoglobin A,hemoglobin S, hemoglobin C, hemoglobin D, hemoglobin E, hemoglobin F,D-Punjab, beta-thalassemia, hepatitis B virus, HCMV, HIV-1, HTLV-1,Leber hereditary optic neuropathy, MCAD, RNA, PKU, Plasmodium vivax,sexual differentiation, 21-deoxycortisol); desbutylhalofantrine;dihydropteridine reductase; diptheria/tetanus antitoxin; erythrocytearginase; erythrocyte protoporphyrin; esterase D; fattyacids/acylglycines; free β-human chorionic gonadotropin; freeerythrocyte porphyrin; free thyroxine (FT4); free tri-iodothyronine(FT3); fumarylacetoacetase; galactose/gal-1-phosphate;galactose-1-phosphate uridyltransferase; gentamicin; analyte-6-phosphatedehydrogenase; glutathione; glutathione perioxidase; glycocholic acid;glycosylated hemoglobin; halofantrine; hemoglobin variants;hexosaminidase A; human erythrocyte carbonic anhydrase I;17-alpha-hydroxyprogesterone; hypoxanthine phosphoribosyl transferase;immunoreactive trypsin; lactate; lead; lipoproteins ((a), B/A-1, β);lysozyme; mefloquine; netilmicin; phenobarbitone; phenytoin;phytanic/pristanic acid; progesterone; prolactin; prolidase; purinenucleoside phosphorylase; quinine; reverse tri-iodothyronine (rT3);selenium; serum pancreatic lipase; sissomicin; somatomedin C; specificantibodies (adenovirus, anti-nuclear antibody, anti-zeta antibody,arbovirus, Aujeszky's disease virus, dengue virus, Dracunculusmedinensis, Echinococcus granulosus, Entamoeba histolytica, enterovirus,Giardia duodenalisa, Helicobacter pylori, hepatitis B virus, herpesvirus, HIV-1, IgE (atopic disease), influenza virus, Leishmaniadonovani, leptospira, measles/mumps/rubella, Mycobacterium leprae,Mycoplasma pneumoniae, Myoglobin, Onchocerca volvulus, parainfluenzavirus, Plasmodium falciparum, poliovirus, Pseudomonas aeruginosa,respiratory syncytial virus, rickettsia (scrub typhus), Schistosomamansoni, Toxoplasma gondii, Trepenoma pallidium, Trypanosomacruzi/rangeli, vesicular stomatis virus, Wuchereria bancrofti, yellowfever virus); specific antigens (hepatitis B virus, HIV-1);succinylacetone; sulfadoxine; theophylline; thyrotropin (TSH); thyroxine(T4); thyroxine-binding globulin; trace elements; transferrin;UDP-galactose-4-epimerase; urea; uroporphyrinogen I synthase; vitamin A;white blood cells; and zinc protoporphyrin. Salts, sugar, protein, fat,vitamins, and hormones naturally occurring in blood or interstitialfluids can also constitute analytes in certain embodiments. The analytecan be naturally present in the biological fluid, for example, ametabolic product, a hormone, an antigen, an antibody, and the like.Alternatively, the analyte can be introduced into the body, for example,a contrast agent for imaging, a radioisotope, a chemical agent, afluorocarbon-based synthetic blood, or a drug or pharmaceuticalcomposition, including but not limited to insulin; ethanol; cannabis(marijuana, tetrahydrocannabinol, hashish); inhalants (nitrous oxide,amyl nitrite, butyl nitrite, chlorohydrocarbons, hydrocarbons); cocaine(crack cocaine); stimulants (amphetamines, methamphetamines, Ritalin,Cylert, Preludin, Didrex, PreState, Voranil, Sandrex, Plegine);depressants (barbituates, methaqualone, tranquilizers such as Valium,Librium, Miltown, Serax, Equanil, Tranxene); hallucinogens(phencyclidine, lysergic acid, mescaline, peyote, psilocybin); narcotics(heroin, codeine, morphine, opium, meperidine, Percocet, Percodan,Tussionex, Fentanyl, Darvon, Talwin, Lomotil); designer drugs (analogsof fentanyl, meperidine, amphetamines, methamphetamines, andphencyclidine, for example, Ecstasy); anabolic steroids; and nicotine.The metabolic products of drugs and pharmaceutical compositions are alsocontemplated analytes. Analytes such as neurochemicals and otherchemicals generated within the body can also be analyzed, such as, forexample, ascorbic acid, uric acid, dopamine, noradrenaline,3-methoxytyramine (3MT), 3,4-Dihydroxyphenylacetic acid (DOPAC),Homovanillic acid (HVA), 5-Hydroxytryptamine (5HT), and5-Hydroxyindoleacetic acid (FHIAA).

The terms “microprocessor” and “processor” as used herein are broadterms and are to be given their ordinary and customary meaning to aperson of ordinary skill in the art (and are not to be limited to aspecial or customized meaning), and furthermore refer without limitationto a computer system, state machine, and the like that performsarithmetic and logic operations using logic circuitry that responds toand processes the basic instructions that drive a computer.

The term “calibration” as used herein is a broad term and is to be givenits ordinary and customary meaning to a person of ordinary skill in theart (and is not to be limited to a special or customized meaning), andfurthermore refers without limitation to the process of determining therelationship between the sensor data and the corresponding referencedata, which can be used to convert sensor data into meaningful valuessubstantially equivalent to the reference data, with or withoututilizing reference data in real time. In some embodiments, namely, inanalyte sensors, calibration can be updated or recalibrated (at thefactory, in real time and/or retrospectively) over time as changes inthe relationship between the sensor data and reference data occur, forexample, due to changes in sensitivity, baseline, transport, metabolism,and the like.

The terms “calibrated data” and “calibrated data stream” as used hereinare broad terms and are to be given their ordinary and customary meaningto a person of ordinary skill in the art (and are not to be limited to aspecial or customized meaning), and furthermore refer without limitationto data that has been transformed from its raw state to another stateusing a function, for example a conversion function, including by use ofa sensitivity, to provide a meaningful value to a user.

The term “algorithm” as used herein is a broad term and is to be givenits ordinary and customary meaning to a person of ordinary skill in theart (and is not to be limited to a special or customized meaning), andfurthermore refers without limitation to a computational process (forexample, programs) involved in transforming information from one stateto another, for example, by using computer processing.

The term “sensor” as used herein is a broad term and is to be given itsordinary and customary meaning to a person of ordinary skill in the art(and is not to be limited to a special or customized meaning), andfurthermore refers without limitation to the component or region of adevice by which an analyte can be quantified. A “lot” of sensorsgenerally refers to a group of sensors that are manufactured on oraround the same day and using the same processes and tools/materials.Additionally, sensors that measure temperature, pressure etc. may bereferred to as a “sensor”.

The terms “glucose sensor” and “member for determining the amount ofglucose in a biological sample” as used herein are broad terms and areto be given their ordinary and customary meaning to a person of ordinaryskill in the art (and are not to be limited to a special or customizedmeaning), and furthermore refer without limitation to any mechanism(e.g., enzymatic or non-enzymatic) by which glucose can be quantified.For example, some embodiments utilize a membrane that contains glucoseoxidase that catalyzes the conversion of oxygen and glucose to hydrogenperoxide and gluconate, as illustrated by the following chemicalreaction:Glucose+O₂→Gluconate+H₂O₂

Because for each glucose molecule metabolized, there is a proportionalchange in the co-reactant O₂ and the product H₂O₂, one can use anelectrode to monitor the current change in either the co-reactant or theproduct to determine glucose concentration.

The terms “operably connected” and “operably linked” as used herein arebroad terms and are to be given their ordinary and customary meaning toa person of ordinary skill in the art (and are not to be limited to aspecial or customized meaning), and furthermore refer without limitationto one or more components being linked to another component(s) in amanner that allows transmission of signals between the components. Forexample, one or more electrodes can be used to detect the amount ofglucose in a sample and convert that information into a signal, e.g., anelectrical or electromagnetic signal; the signal can then be transmittedto an electronic circuit. In this case, the electrode is “operablylinked” to the electronic circuitry. These terms are broad enough toinclude wireless connectivity.

The term “determining” encompasses a wide variety of actions. Forexample, “determining” may include calculating, computing, processing,deriving, investigating, looking up (e.g., looking up in a table, adatabase or another data structure), ascertaining and the like. Also,“determining” may include receiving (e.g., receiving information),accessing (e.g., accessing data in a memory) and the like. Also,“determining” may include resolving, selecting, choosing, calculating,deriving, establishing and/or the like. Determining may also includeascertaining that a parameter matches a predetermined criterion,including that a threshold has been met, passed, exceeded, and so on.

The term “substantially” as used herein is a broad term and is to begiven its ordinary and customary meaning to a person of ordinary skillin the art (and is not to be limited to a special or customizedmeaning), and furthermore refers without limitation to being largely butnot necessarily wholly that which is specified.

The term “host” as used herein is a broad term and is to be given itsordinary and customary meaning to a person of ordinary skill in the art(and is not to be limited to a special or customized meaning), andfurthermore refers without limitation to mammals, particularly humans.

The term “continuous analyte (or glucose) sensor” as used herein is abroad term and is to be given its ordinary and customary meaning to aperson of ordinary skill in the art (and is not to be limited to aspecial or customized meaning), and furthermore refers withoutlimitation to a device that continuously or continually measures aconcentration of an analyte, for example, at time intervals ranging fromfractions of a second up to, for example, 1, 2, or 5 minutes, or longer.In one exemplary embodiment, the continuous analyte sensor is a glucosesensor such as described in U.S. Pat. No. 6,001,067, which isincorporated herein by reference in its entirety.

The term “sensing membrane” as used herein is a broad term and is to begiven its ordinary and customary meaning to a person of ordinary skillin the art (and is not to be limited to a special or customizedmeaning), and furthermore refers without limitation to a permeable orsemi-permeable membrane that can be comprised of two or more domains andis typically constructed of materials of a few microns thickness ormore, which are permeable to oxygen and may or may not be permeable toglucose. In one example, the sensing membrane comprises an immobilizedglucose oxidase enzyme, which enables an electrochemical reaction tooccur to measure a concentration of glucose.

The term “sensor data,” as used herein is a broad term and is to begiven its ordinary and customary meaning to a person of ordinary skillin the art (and are not to be limited to a special or customizedmeaning), and furthermore refers without limitation to any dataassociated with a sensor, such as a continuous analyte sensor. Sensordata includes a raw data stream, or simply data stream, of analog ordigital signals directly related to a measured analyte from an analytesensor (or other signal received from another sensor), as well ascalibrated and/or filtered raw data. In one example, the sensor datacomprises digital data in “counts” converted by an A/D converter from ananalog signal (e.g., voltage or amps) and includes one or more datapoints representative of a glucose concentration. Thus, the terms“sensor data point” and “data point” refer generally to a digitalrepresentation of sensor data at a particular time. The terms broadlyencompass a plurality of time spaced data points from a sensor, such asfrom a substantially continuous glucose sensor, which comprisesindividual measurements taken at time intervals ranging from fractionsof a second up to, e.g., 1, 2, or 5 minutes or longer. In anotherexample, the sensor data includes an integrated digital valuerepresentative of one or more data points averaged over a time period.Sensor data may include calibrated data, smoothed data, filtered data,transformed data, and/or any other data associated with a sensor.

The term “sensor electronics,” as used herein, is a broad term, and isto be given its ordinary and customary meaning to a person of ordinaryskill in the art (and is not to be limited to a special or customizedmeaning), and refers without limitation to the components (for example,hardware and/or software) of a device configured to process data. Asdescribed in further detail hereinafter (see, e.g., FIG. 2 ) “sensorelectronics” may be arranged and configured to measure, convert, store,transmit, communicate, and/or retrieve sensor data associated with ananalyte sensor.

The terms “sensitivity” or “sensor sensitivity,” as used herein, arebroad terms, and are to be given their ordinary and customary meaning toa person of ordinary skill in the art (and is not to be limited to aspecial or customized meaning), and refer without limitation to anamount of signal produced by a certain concentration of a measuredanalyte, or a measured species (e.g., H2O2) associated with the measuredanalyte (e.g., glucose). For example, in one embodiment, a sensor has asensitivity from about 1 to about 300 picoAmps of current for every 1mg/dL of glucose analyte.

The term “sample,” as used herein, is a broad term, and is to be givenits ordinary and customary meaning to a person of ordinary skill in theart (and it is not to be limited to a special or customized meaning),and refers without limitation to a sample of a host body, for example,body fluids, including, blood, serum, plasma, interstitial fluid,cerebral spinal fluid, lymph fluid, ocular fluid, saliva, oral fluid,urine, excretions, or exudates.

The term “distal to,” as used herein, is a broad term, and is to begiven its ordinary and customary meaning to a person of ordinary skillin the art (and is not to be limited to a special or customizedmeaning), and refers without limitation to the spatial relationshipbetween various elements in comparison to a particular point ofreference. In general, the term indicates an element is locatedrelatively far from the reference point than another element.

The term “proximal to,” as used herein, is a broad term, and is to begiven its ordinary and customary meaning to a person of ordinary skillin the art (and is not to be limited to a special or customizedmeaning), and refers without limitation to the spatial relationshipbetween various elements in comparison to a particular point ofreference. In general, the term indicates an element is locatedrelatively near to the reference point than another element.

The terms “electrical connection” and “electrical contact,” as usedherein, are broad terms, and are to be given their ordinary andcustomary meaning to a person of ordinary skill in the art (and are notto be limited to a special or customized meaning), and refer withoutlimitation to any connection between two electrical conductors known tothose in the art. In one embodiment, electrodes are in electricalconnection with (e.g., electrically connected to) the electroniccircuitry of a device. In another embodiment, two materials, such as butnot limited to two metals, can be in electrical contact with each other,such that an electrical current can pass from one of the two materialsto the other material and/or an electrical potential can be applied.

The term “elongated conductive body,” as used herein, is a broad term,and is to be given its ordinary and customary meaning to a person ofordinary skill in the art (and is not to be limited to a special orcustomized meaning), and refers without limitation to an elongated bodyformed at least in part of a conductive material and includes any numberof coatings that may be formed thereon. By way of example, an “elongatedconductive body” may mean a bare elongated conductive core (e.g., ametal wire), an elongated conductive core coated with one, two, three,four, five, or more layers of material, each of which may or may not beconductive, or an elongated non-conductive core with conductivecoatings, traces, and/or electrodes thereon and coated with one, two,three, four, five, or more layers of material, each of which may or maynot be conductive.

The term “ex vivo portion,” as used herein, is a broad term, and is tobe given its ordinary and customary meaning to a person of ordinaryskill in the art (and is not to be limited to a special or customizedmeaning), and refers without limitation to a portion of a device (forexample, a sensor) adapted to remain and/or exist outside of a livingbody of a host.

The term “in vivo portion,” as used herein, is a broad term, and is tobe given its ordinary and customary meaning to a person of ordinaryskill in the art (and is not to be limited to a special or customizedmeaning), and refers without limitation to a portion of a device (forexample, a sensor) adapted for insertion into and/or existence within aliving body of a host.

The term “potentiostat,” as used herein, is a broad term, and is to begiven its ordinary and customary meaning to a person of ordinary skillin the art (and is not to be limited to a special or customizedmeaning), and refers without limitation to an electronic instrument thatcontrols the electrical potential between the working and referenceelectrodes at one or more preset values.

The term “processor module,” as used herein, is a broad term, and is tobe given its ordinary and customary meaning to a person of ordinaryskill in the art (and are not to be limited to a special or customizedmeaning), and refers without limitation to a computer system, statemachine, processor, components thereof, and the like designed to performarithmetic or logic operations using logic circuitry that responds toand processes the basic instructions that drive a computer.

The term “sensor session,” as used herein, is a broad term and is to begiven its ordinary and customary meaning to a person of ordinary skillin the art (and is not to be limited to a special or customizedmeaning), and refers without limitation to a period of time a sensor isin use, such as but not limited to a period of time starting at the timethe sensor is implanted (e.g., by the host) to removal of the sensor(e.g., removal of the sensor from the host's body and/or removal of(e.g., disconnection from) system electronics).

The terms “substantial” and “substantially,” as used herein, are broadterms, and are to be given their ordinary and customary meaning to aperson of ordinary skill in the art (and are not to be limited to aspecial or customized meaning), and refer without limitation to asufficient amount that provides a desired function.

“Coaxial two conductor wire based sensor”: A round wire sensorconsisting of a conductive center core, an insulating middle layer and aconductive outer layer with the conductive layers exposed at one end forelectrical contact.

“Pre-connected sensor”: A sensor that has a “sensorinterconnect/interposer/sensor carrier” attached to it. Therefore this“Pre-connected sensor” consists of two parts that are joined: the sensoritself, and the interconnect/interposer/sensor carrier. The term“pre-connected sensor” unit refers to the unit that is formed by thepermanent union of these two distinct parts.

Other definitions will be provided within the description below, and insome cases from the context of the term's usage.

As employed herein, the following abbreviations apply: Eq and Eqs(equivalents); mEq (milliequivalents); M (molar); mM (millimolar) μM(micromolar); N (Normal); mol (moles); mmol (millimoles); μmol(micromoles); nmol (nanomoles); g (grams); mg (milligrams); μg(micrograms); Kg (kilograms); L (liters); mL (milliliters); dL(deciliters); μL (microliters); cm (centimeters); mm (millimeters); μm(micrometers); nm (nanometers); h and hr (hours); min. (minutes); s andsec. (seconds); ° C. (degrees Centigrade) ° F. (degrees Fahrenheit), Pa(Pascals), kPa (kiloPascals), mPa (megaPascals), GPa (gigaPascals), Psi(pounds per square inch), kPsi (kilopounds per square inch).

Overview/General Description of System

In vivo analyte sensing technology may rely on in vivo sensors. In vivosensors may include an elongated conductive body having one or moreelectrodes such as a working electrode and a reference electrode.

For example, a platinum metal-clad, tantalum wire is sometimes used as acore bare sensing element with one or more reference or counterelectrodes for an analyte sensor. This sensing element is coated inmembranes to yield the final sensor.

Described herein are pre-connected sensors that include an analytesensor attached to a sensor carrier (also referred to herein as a“sensor interposer”). The analyte sensor may include a working electrodeand a reference electrode at a distal end of an elongated conductivebody. The sensor carrier may include a substrate, one or more electricalcontacts coupled to one or more electrical contacts of the sensor, andcircuitry such as one or more additional or external electrical contactsfor coupling the one or more electrical contacts that are coupled to thesensor contact(s) to external equipment such as a membrane dip coatingstation, a testing station, a calibration station, or sensor electronicsof a wearable device. In some embodiments, the substrate can be referredto as an intermediate body.

The following description and examples described the present embodimentswith reference to the drawings. In the drawings, reference numbers labelelements of the present embodiments. These reference numbers arereproduced below in connection with the discussion of the correspondingdrawing features.

Sensor System

FIG. 1 depicts an example system 100, in accordance with some exampleimplementations. The system 100 includes an analyte sensor system 101including sensor electronics 112 and an analyte sensor 138. The system100 may include other devices and/or sensors, such as medicamentdelivery pump 102 and glucose meter 104. The analyte sensor 138 may bephysically connected to sensor electronics 112 and may be integral with(e.g., non-releasably attached to) or releasably attachable to thesensor electronics. For example, continuous analyte sensor 138 may beconnected to sensor electronics 112 via a sensor carrier thatmechanically and electrically interfaces the analyte sensor 138 with thesensor electronics. The sensor electronics 112, medicament delivery pump102, and/or glucose meter 104 may couple with one or more devices, suchas display devices 114, 116, 118, and/or 120.

In some example implementations, the system 100 may include acloud-based analyte processor 490 configured to analyze analyte data(and/or other patient-related data) provided via network 409 (e.g., viawired, wireless, or a combination thereof) from sensor system 101 andother devices, such as display devices 114, 116, 118, and/or 120 and thelike, associated with the host (also referred to as a patient) andgenerate reports providing high-level information, such as statistics,regarding the measured analyte over a certain time frame. A fulldiscussion of using a cloud-based analyte processing system may be foundin U.S. patent application Ser. No. 13/788,375, entitled “Cloud-BasedProcessing of Analyte Data” and filed on Mar. 7, 2013, published as U.S.Patent Application Publication 2013/0325352, herein incorporated byreference in its entirety. In some implementations, one or more steps ofthe factory calibration algorithm can be performed in the cloud.

In some example implementations, the sensor electronics 112 may includeelectronic circuitry associated with measuring and processing datagenerated by the analyte sensor 138. This generated analyte sensor datamay also include algorithms, which can be used to process and calibratethe analyte sensor data, although these algorithms may be provided inother ways as well. The sensor electronics 112 may include hardware,firmware, software, or a combination thereof, to provide measurement oflevels of the analyte via an analyte sensor, such as a glucose sensor.An example implementation of the sensor electronics 112 is describedfurther below with respect to FIG. 2 .

In one implementation, the factory calibration algorithms describedherein may be performed by the sensor electronics.

The sensor electronics 112 may, as noted, couple (e.g., wirelessly andthe like) with one or more devices, such as display devices 114, 116,118, and/or 120. The display devices 114, 116, 118, and/or 120 may beconfigured for presenting information (and/or alarming), such as sensorinformation transmitted by the sensor electronics 112 for display at thedisplay devices 114, 116, 118, and/or 120.

In one implementation, the factory calibration algorithms describedherein may be performed at least in part by the display devices.

In some example implementations, the relatively small, key fob-likedisplay device 114 may comprise a wrist watch, a belt, a necklace, apendent, a piece of jewelry, an adhesive patch, a pager, a key fob, aplastic card (e.g., credit card), an identification (ID) card, and/orthe like. This small display device 114 may include a relatively smalldisplay (e.g., smaller than the large display device 116) and may beconfigured to display certain types of displayable sensor information,such as a numerical value, and an arrow, or a color code.

In some example implementations, the relatively large, hand-held displaydevice 116 may comprise a hand-held receiver device, a palm-topcomputer, and/or the like. This large display device may include arelatively larger display (e.g., larger than the small display device114) and may be configured to display information, such as a graphicalrepresentation of the sensor data including current and historic sensordata output by sensor system 100.

In some example implementations, the analyte sensor 138 may comprise aglucose sensor configured to measure glucose in the blood orinterstitial fluid using one or more measurement techniques, such asenzymatic, chemical, physical, electrochemical, spectrophotometric,polarimetric, calorimetric, iontophoretic, radiometric, immunochemical,and the like. In implementations in which the analyte sensor 138includes a glucose sensor, the glucose sensor may comprise any devicecapable of measuring the concentration of glucose and may use a varietyof techniques to measure glucose including invasive, minimally invasive,and non-invasive sensing techniques (e.g., fluorescence monitoring), toprovide data, such as a data stream, indicative of the concentration ofglucose in a host. The data stream may be sensor data (raw and/orfiltered), which may be converted into a calibrated data stream used toprovide a value of glucose to a host, such as a user, a patient, or acaretaker (e.g., a parent, a relative, a guardian, a teacher, a doctor,a nurse, or any other individual that has an interest in the wellbeingof the host). Moreover, the analyte sensor 138 may be implanted as atleast one of the following types of analyte sensors: an implantableglucose sensor, a transcutaneous glucose sensor, implanted in a hostvessel or extracorporeally, a subcutaneous sensor, a refillablesubcutaneous sensor, an intravascular sensor.

Although the disclosure herein refers to some implementations thatinclude an analyte sensor 138 comprising a glucose sensor, the analytesensor 138 may comprise other types of analyte sensors as well.Moreover, although some implementations refer to the glucose sensor asan implantable glucose sensor, other types of devices capable ofdetecting a concentration of glucose and providing an output signalrepresentative of glucose concentration may be used as well.Furthermore, although the description herein refers to glucose as theanalyte being measured, processed, and the like, other analytes may beused as well including, for example, ketone bodies (e.g., acetone,acetoacetic acid and beta hydroxybutyric acid, lactate, etc.), glucagon,acetyl-CoA, triglycerides, fatty acids, intermediaries in the citricacid cycle, choline, insulin, cortisol, testosterone, and the like.

In some manufacturing systems, sensors 138 are manually sorted, placedand held in fixtures. These fixtures are manually moved from station tostation during manufacturing for various process steps includinginterfacing electrical measurement equipment for testing and calibrationoperations. However, manual handling of sensors can be inefficient, cancause delays due to non-ideal mechanical and electrical connections, andcan risk damage to the sensor and/or testing and calibration equipmentand can induce sensor variability that can lead to inaccurateverification data being collected in manufacturing. In addition, theprocess of packaging sensor 138 with the sensor electronics 112 into awearable device involves further manual manipulation of the sensor thatcan damage the sensor 138.

Various systems, devices, and methods described herein help to reduce oreliminate manual interaction with a sensor. For example, a pre-connectedsensor may be provided that includes a sensor interconnect or sensorcarrier electrically coupled to sensor electrodes and having mechanicaland electrical features configured to accurately interface with wearableelectronics, automation equipment and/or robustly connect to measurementequipment.

Identification and other data associated with each sensor may be storedon the sensor carrier for logging and tracking of each sensor duringmanufacturing, testing, calibration, and in vivo operations. Followingtesting and calibration operations, the sensor carrier may be used toconnect the sensor to sensor electronics of a wearable device, such asan on-skin sensor assembly, in an arrangement that is sealed andelectrically robust.

FIG. 2 depicts an example of electronics 112 that may be used in sensorelectronics 112 or may be implemented in a manufacturing station such asa testing station, a calibration station, a smart carrier, or otherequipment used during manufacturing of device 101, in accordance withsome example implementations. The sensor electronics 112 may includeelectronics components that are configured to process sensorinformation, such as sensor data, and generate transformed sensor dataand displayable sensor information, e.g., via a processor module. Forexample, the processor module may transform sensor data into one or moreof the following: filtered sensor data (e.g., one or more filteredanalyte concentration values), raw sensor data, calibrated sensor data(e.g., one or more calibrated analyte concentration values), rate ofchange information, trend information, rate of acceleration/decelerationinformation, sensor diagnostic information, location information,alarm/alert information, calibration information such as may bedetermined by factory calibration algorithms as disclosed herein,smoothing and/or filtering algorithms of sensor data, and/or the like.

In some embodiments, a processor module 214 is configured to achieve asubstantial portion, if not all, of the data processing, including dataprocessing pertaining to factory calibration. Processor module 214 maybe integral to sensor electronics 112 and/or may be located remotely,such as in one or more of devices 114, 116, 118, and/or 120 and/or cloud490. For example, in some embodiments, processor module 214 may belocated at least partially within a cloud-based analyte processor 490 orelsewhere in network 409.

In some example implementations, the processor module 214 may beconfigured to calibrate the sensor data, and the data storage memory 220may store the calibrated sensor data points as transformed sensor data.Moreover, the processor module 214 may be configured, in some exampleimplementations, to wirelessly receive calibration information from adisplay device, such as devices 114, 116, 118, and/or 120, to enablecalibration of the sensor data from sensor 138. Furthermore, theprocessor module 214 may be configured to perform additional algorithmicprocessing on the sensor data (e.g., calibrated and/or filtered dataand/or other sensor information), and the data storage memory 220 may beconfigured to store the transformed sensor data and/or sensor diagnosticinformation associated with the algorithms. The processor module 214 mayfurther be configured to store and use calibration informationdetermined from a factory calibration, as described below.

In some example implementations, the sensor electronics 112 may comprisean application-specific integrated circuit (ASIC) 205 coupled to a userinterface 222. The ASIC 205 may further include a potentiostat 210, atelemetry module 232 for transmitting data from the sensor electronics112 to one or more devices, such as devices 114, 116, 118, and/or 120,and/or other components for signal processing and data storage (e.g.,processor module 214 and data storage memory 220). Although FIG. 2depicts ASIC 205, other types of circuitry may be used as well,including field programmable gate arrays (FPGA), one or moremicroprocessors configured to provide some (if not all of) theprocessing performed by the sensor electronics 12, analog circuitry,digital circuitry, or a combination thereof.

In the example depicted in FIG. 2 , through a first input port 211 forsensor data the potentiostat 210 is coupled to an analyte sensor 138,such as a glucose sensor to generate sensor data from the analyte. Thepotentiostat 210 may be coupled to a working electrode 211 and referenceelectrode 212 that form a part of the sensor 138. The potentiostat mayprovide a voltage to one of the electrodes 211, 212 of the analytesensor 138 to bias the sensor for measurement of a value (e.g., acurrent) indicative of the analyte concentration in a host (alsoreferred to as the analog portion of the sensor). The potentiostat 210may have one or more connections to the sensor 138 depending on thenumber of electrodes incorporated into the analyte sensor 138 (such as acounter electrode as a third electrode).

In some example implementations, the potentiostat 210 may include aresistor that translates a current value from the sensor 138 into avoltage value, while in some example implementations, acurrent-to-frequency converter (not shown) may also be configured tointegrate continuously a measured current value from the sensor 138using, for example, a charge-counting device. In some exampleimplementations, an analog-to-digital converter (not shown) may digitizethe analog signal from the sensor 138 into so-called “counts” to allowprocessing by the processor module 214. The resulting counts may bedirectly related to the current measured by the potentiostat 210, whichmay be directly related to an analyte level, such as a glucose level, inthe host.

The telemetry module 232 may be operably connected to processor module214 and may provide the hardware, firmware, and/or software that enablewireless communication between the sensor electronics 112 and one ormore other devices, such as display devices, processors, network accessdevices, and the like. A variety of wireless radio technologies that canbe implemented in the telemetry module 232 include Bluetooth, BluetoothLow-Energy, ANT, ANT+, ZigBee, IEEE 802.11, IEEE 802.16, cellular radioaccess technologies, radio frequency (RF), infrared (IR), paging networkcommunication, magnetic induction, satellite data communication, spreadspectrum communication, frequency hopping communication, near fieldcommunications, and/or the like. In some example implementations, thetelemetry module 232 comprises a Bluetooth chip, although Bluetoothtechnology may also be implemented in a combination of the telemetrymodule 232 and the processor module 214.

The processor module 214 may control the processing performed by thesensor electronics 112. For example, the processor module 214 may beconfigured to process data (e.g., counts), from the sensor, filter thedata, calibrate the data, perform fail-safe checking, and/or the like.

Potentiostat 210 may measure the analyte (e.g., glucose and/or the like)at discrete time intervals or continuously, for example, using acurrent-to-voltage or current-to-frequency converter.

The processor module 214 may further include a data generator (notshown) configured to generate data packages for transmission to devices,such as the display devices 114, 116, 118, and/or 120. Furthermore, theprocessor module 214 may generate data packets for transmission to theseoutside sources via telemetry module 232. In some exampleimplementations, the data packages may include an identifier code forthe sensor and/or sensor electronics 112, raw data, filtered data,calibrated data, rate of change information, trend information, errordetection or correction, and/or the like.

The processor module 214 may also include a program memory 216 and othermemory 218. The processor module 214 may be coupled to a communicationsinterface, such as a communication port 238, and a source of power, suchas a battery 234. Moreover, the battery 234 may be further coupled to abattery charger and/or regulator 236 to provide power to sensorelectronics 112 and/or charge the battery 234.

The program memory 216 may be implemented as a semi-static memory forstoring data, such as an identifier for a coupled sensor 138 (e.g., asensor identifier (ID)) and for storing code (also referred to asprogram code) to configure the ASIC 205 to perform one or more of theoperations/functions described herein. For example, the program code mayconfigure processor module 214 to process data streams or counts,filter, perform the calibration methods described below, performfail-safe checking, and the like.

The memory 218 may also be used to store information. For example, theprocessor module 214 including memory 218 may be used as the system'scache memory, where temporary storage is provided for recent sensor datareceived from the sensor. In some example implementations, the memorymay comprise memory storage components, such as read-only memory (ROM),random-access memory (RAM), dynamic-RAM, static-RAM, non-static RAM,electrically erasable programmable read only memory (EEPROM), rewritableROMs, flash memory, and the like.

The data storage memory 220 may be coupled to the processor module 214and may be configured to store a variety of sensor information. In someexample implementations, the data storage memory 220 stores one or moredays of analyte sensor data. The stored sensor information may includeone or more of the following: a time stamp, raw sensor data (one or moreraw analyte concentration values), calibrated data, filtered data,transformed sensor data, and/or any other displayable sensorinformation, calibration information (e.g., reference BG values and/orprior calibration information such as from factory calibration), sensordiagnostic information, and the like.

The user interface 222 may include a variety of interfaces, such as oneor more buttons 224, a liquid crystal display (LCD) 226, a vibrator 228,an audio transducer (e.g., speaker) 230, a backlight (not shown), and/orthe like. The components that comprise the user interface 222 mayprovide controls to interact with the user (e.g., the host).

The battery 234 may be operatively connected to the processor module 214(and possibly other components of the sensor electronics 12) and providethe necessary power for the sensor electronics 112. In otherimplementations, the receiver can be transcutaneously powered via aninductive coupling, for example.

A battery charger and/or regulator 236 may be configured to receiveenergy from an internal and/or external charger. In some exampleimplementations, the battery 234 (or batteries) is configured to becharged via an inductive and/or wireless charging pad, although anyother charging and/or power mechanism may be used as well.

One or more communication ports 238, also referred to as externalconnector(s), may be provided to allow communication with other devices,for example a PC communication (com) port can be provided to enablecommunication with systems that are separate from, or integral with, thesensor electronics 112. The communication port, for example, maycomprise a serial (e.g., universal serial bus or “USB”) communicationport, and allow for communicating with another computer system (e.g.,PC, personal digital assistant or “PDA,” server, or the like). In someexample implementations, factory information may be sent to thealgorithm from the sensor or from a cloud data source.

The one or more communication ports 238 may further include an inputport 237 in which calibration data may be received, and an output port239 which may be employed to transmit calibrated data, or data to becalibrated, to a receiver or mobile device. FIG. 2 illustrates theseaspects schematically. It will be understood that the ports may beseparated physically, but in alternative implementations a singlecommunication port may provide the functions of both the second inputport and the output port.

In some analyte sensor systems, an on-skin portion of the sensorelectronics may be simplified to minimize complexity and/or size ofon-skin electronics, for example, providing only raw, calibrated, and/orfiltered data to a display device configured to run calibration andother algorithms required for displaying the sensor data. However, thesensor electronics 112 (e.g., via processor module 214) may beimplemented to execute prospective algorithms used to generatetransformed sensor data and/or displayable sensor information,including, for example, algorithms that: evaluate a clinicalacceptability of reference and/or sensor data, evaluate calibration datafor best calibration based on inclusion criteria, evaluate a quality ofthe calibration, compare estimated analyte values with timecorresponding measured analyte values, analyze a variation of estimatedanalyte values, evaluate a stability of the sensor and/or sensor data,detect signal artifacts (noise), replace signal artifacts, determine arate of change and/or trend of the sensor data, perform dynamic andintelligent analyte value estimation, perform diagnostics on the sensorand/or sensor data, set modes of operation, evaluate the data foraberrancies, and/or the like.

FIGS. 3A, 3B, and 3C illustrate an exemplary implementation of analytesensor system 101 implemented as a wearable device such as an on-skinsensor assembly 600. As shown in FIG. 3 , on-skin sensor assemblycomprises a housing 128. An adhesive patch 126 can couple the housing128 to the skin of the host. The adhesive 126 can be a pressuresensitive adhesive (e.g. acrylic, rubber based, or other suitable type)bonded to a carrier substrate (e.g., spun lace polyester, polyurethanefilm, or other suitable type) for skin attachment. The housing 128 mayinclude a through-hole 180 that cooperates with a sensor inserter device(not shown) that is used for implanting the sensor 138 under the skin ofa subject.

The wearable sensor assembly 600 can include sensor electronics 112operable to measure and/or analyze glucose indicators sensed by glucosesensor 138. Sensor electronics 112 within sensor assembly 600 cantransmit information (e.g., measurements, analyte data, and glucosedata) to a remotely located device (e.g., 114, 116, 118, 120 shown inFIG. 1 ). As shown in FIG. 3C, in this implementation the sensor 138extends from its distal end up into the through-hole 180 and is routedto an electronics module 135 inside the enclosure 128. The workingelectrode 211 and reference electrode 212 are connected to circuitry inthe electronics module 135 which includes the potentiostat.

FIG. 3D illustrates one exemplary embodiment of an analyte sensor 138which includes an elongated body portion. The elongated body portion maybe long and thin, yet flexible and strong. For example, in someembodiments, the smallest dimension of the elongated conductive body isless than about 0.1 inches, 0.075 inches, 0.05 inches, 0.025 inches,0.01 inches, 0.004 inches, or 0.002 inches. While the elongatedconductive body is illustrated herein as having a circularcross-section, in other embodiments the cross-section of the elongatedconductive body can be ovoid, rectangular, triangular, or polyhedral,star-shaped, C-shaped, T-shaped, X-shaped, Y-shaped, irregular, or thelike.

In the implementation of FIG. 3D, the analyte sensor 138 comprises awire core 139. At a distal, in vivo portion of the sensor 138, the wirecore 139 forms an electrode 211 a. At a proximal, ex vivo portion of thesensor 138, the wire core 139 forms a contact 211 b. The electrode 211 aand the contact 211 b are in electrical communication over the length ofthe wire core 139 as it extends along the elongated body portion of thesensor 138. The wire core can be made from a single material such asplatinum or tantalum, or may be formed as multiple layers, such as aconducting or non-conducting material with an outer coating of adifferent conducting material.

A layer 104 surrounds a least a portion of the wire core 139. The layer104 may be formed of an insulating material, such as polyimide,polyurethane, parylene, or any other known insulating materials. Forexample, in one embodiment the layer 104 is disposed on the wire core139 and configured such that the electrode 211 a is exposed via window106.

In some embodiments, the sensor 138 further comprises a layer 141surrounding the insulating layer 104 like a sleeve that comprises aconductive material. At a distal, in vivo portion of the sensor 138, thesleeve layer 141 forms an electrode 212 a. At a proximal, ex vivoportion of the sensor 138, the sleeve layer 141 forms a contact 212 b.The electrode 212 a and the contact 212 b are in electricalcommunication over the length of the sleeve layer 141 as it extendsalong the elongated body portion of the sensor 138. This sleeve layer141 may be formed of a silver-containing material that is applied ontothe insulating layer 104. The silver-containing material may include anyof a variety of materials and be in various forms, such as,Ag/AgCl-polymer pastes, paints, polymer-based conducting mixture, and/orinks that are commercially available, for example. This layer 141 can beprocessed using a pasting/dipping/coating step, for example, using adie-metered dip coating process. In one exemplary embodiment, an Ag/AgClpolymer paste is applied to an elongated body by dip-coating the body(e.g., using a meniscus coating technique) and then drawing the bodythrough a die to meter the coating to a precise thickness. In someembodiments, multiple coating steps are used to build up the coating toa predetermined thickness.

The sensor 138 shown in FIG. 3D also includes a membrane 108 covering atleast a portion of the distal in vivo portion of the sensor 138. Thismembrane is typically formed of multiple layers, which may include oneor more of an interference domain, an enzyme domain, a diffusionresistance domain, and a bioprotective domain. This membrane isimportant to support the electrochemical processes that allow analytedetection and it is generally manufactured with great care bydip-coating, spraying, or other manufacturing steps. It is preferablefor the distal in vivo portion of the sensor 138 to be subject to aslittle handling as possible from the time the membrane 108 is formed tothe time the distal in vivo portion of the sensor 138 is implanted intoa subject. In some embodiments, electrode 211 a forms a workingelectrode of an electrochemical measuring system, and electrode 212 aforms a reference electrode for that system. In use, both electrodes maybe implanted into a host for analyte monitoring.

Although the above description is applicable specifically to a coaxialwire type structure, the embodiments herein are also applicable to otherphysical configurations of electrodes. For example, the two electrodes211 a and 212 a could be affixed to a distal in vivo portion of anelongated flexible strip of a planar substrate such as a thin, flat,polymer flex circuit. The two contacts 211 b and 212 b could be affixedto the proximal ex vivo portion of this flexible planar substrate.Electrodes 211 a, 212 a could be electrically connected to theirrespective contacts 211 b, 212 b a circuit traces on the planarsubstrate. In this case, the electrodes 211 a and 212 a and the contacts211 b and 212 b may be adjacent to one another on a flat surface ratherthan being coaxial as shown in FIG. 3D.

Also shown in FIG. 3D is an illustration of the contact 211 b and thecontact 212 b electrically coupled to a simple current-to-voltageconverter based potentiostat 210. The potentiostat includes a battery320 that has an output coupled to an input of an operational amplifier322. The output of the operational amplifier 322 is coupled to a contact324 that is electrically coupled to the working electrode contact 211 bthrough a resistor 328. The amplifier 322 will bias the contact 324 tothe battery voltage V_(b), and will drive the current i_(m) required tomaintain that bias. This current will flow from the working electrode211 a through the interstitial fluid surrounding the sensor 138 and tothe reference electrode 212 a. The reference electrode contact 212 b iselectrically coupled to another contact 334 which is connected to theother side of the battery 320. For this circuit, the current i_(m) isequal to (V_(b)−V_(M))/R, where V_(M) is the voltage measured at theoutput of the amplifier 322. The magnitude of this current for a givenbias on the working electrode 211 a is a measure of analyteconcentration in the vicinity of the window 106.

The contacts 324 and 334 are typically conductive pads/traces on acircuit board. There is always some level of parasitic leakage currenti_(p) over the surface of this board during the test. If possible, thisleakage current should not form part of the measurement of current dueto analyte. To reduce the effect this leakage current has on themeasured current, an optional additional pad/trace 336 may be providedbetween the biased contact 324 and the return contact 334 that isconnected directly to the battery output. This optional additionalpad/trace may be referred to as a “guard trace.” Because they are heldat the same potential, there will be essentially no leakage current fromthe biased contact 324 and the guard trace 336. Furthermore, leakagecurrent from the guard trace 336 to the return contact 334 does not passthrough the amplifier output resistor 328, and therefore is not includedin the measurement. Additional aspects and implementations of a guardtrace may be found in paragraphs [0128] and [0129] of U.S. PatentPublication 2017/0281092, which are incorporated herein by reference.

During manufacturing, various coating, testing, calibration, andassembly operations are performed on the sensor 138. However, it can bedifficult to transport individual sensors and electrically interface thesensors with multiple testing and calibration equipment installations.These processes also subject the sensors to damage from handling. Tohelp address these issues, the sensor 138 may be provided as a part of apre-connected sensor that includes a sensor carrier as described ingreater detail below.

FIG. 4A shows a schematic illustration of a pre-connected sensor 400. Asshown in FIG. 4A, pre-connected sensor 400 includes sensor carrier 402permanently attached to sensor 138. In the example of FIG. 4A, sensorcarrier 402 includes an intermediate body such as substrate 404, andalso includes one or more contacts such as first internal contact 406,and second internal contact 408. First internal contact 406 iselectrically coupled to a first contact on a proximal end of sensor 138and contact internal contact 408 is electrically coupled to a secondcontact on the proximal end of sensor 138. The distal end of sensor 138is a free end configured for insertion into the skin of the host.Contacts 406 and 408 may, for example, correspond to contacts 324 and334 of FIG. 3D in some implementations.

As shown in FIG. 4A, first internal contact 406 may be electricallycoupled to a first external contact 410 and second internal contact 408may be electrically coupled to a second external contact 412. Asdescribed in further detail hereinafter, external contacts 410 and 412may be configured to electrically interface with sensor electronics 112in wearable device 600. Furthermore, external contacts 410 and 412 maybe configured to electrically interface with processing circuitry ofmanufacturing equipment such one or more testing stations and/or one ormore calibration stations. Although various examples are describedherein in which two external contacts 410 and 412 on the sensor carrierare coupled to two corresponding contacts on sensor 138, this is merelyillustrative. In other implementations, sensor carrier 402 and sensor138 may each be provided with a single contact or may each be providedwith more than two contacts, for example, any N number of externalcontacts (e.g., more than two external contacts 410 and 412) of thesensor carrier and any M number of contacts (e.g., more than twocontacts 406 and 408) of sensor 138 that can be coupled. In someimplementations, sensor carrier 402 and sensor 138 may have the samenumber of contacts (i.e., N=M). In some implementations, sensor carrier402 and sensor 138 may have a different number of contacts (i.e., N≠M).For example, in some implementations, sensor carrier 402 may haveadditional contacts for coupling to or between various components of amanufacturing station.

As described in further detail hereinafter, substrate 404 may beconfigured to couple with sensor electronics 112 in wearable device 600.In some embodiments, substrate 404 may be sized and shaped tomechanically interface with housing 128 and electrically interface withsensor electronics 112 inside housing 128. Further, substrate 404 may besized and shaped to mechanically interface with manufacturing equipment,assembly equipment, testing stations and/or one or more calibrationstations. As described in further detail hereinafter, sensor carrier 402may be attached and/or electrically coupled to sensor 138. Sensor 138may be permanently coupled to a component of sensor carrier 402 (e.g.substrate 404) by using, for example, adhesive (e.g. UV cure, moisturecure, multi part activated, heat cure, hot melt, etc.), includingconductive adhesive (e.g. carbon filled, carbon nanotube filled, silverfilled, conductive additive, etc.), conductive ink, spring contacts,clips, wrapped flexible circuitry, a conductive polymer (e.g. conductiveelastomer, conductive plastic, carbon filled PLA, conductive graphenePLA), conductive foam, conductive fabric, a barrel connector, a moldedinterconnect device structure, sewing, wire wrapping, wire bonding, wirethreading, spot welding, swaging, crimping, stapling, clipping,soldering or brazing, plastic welding, or overmolding. In someembodiments, sensor 138 may be permanently coupled to substrate 404 byrivets, magnets, anisotropic conductive films, metallic foils, or othersuitable structures or materials for mechanically and electricallyattaching sensor carrier 402 to sensor 138 before or during assembly,manufacturing, testing and/or calibration operations. In someembodiments, sensor carrier 402 may be 3-D printed around sensor 138 toform pre-connected sensor 400. Additionally, sensor carrier 402 mayinclude datum features 430 (sometimes referred to as datum structures)such as a recess, an opening, a surface or a protrusion for aligning,positioning, and orienting sensor 138 relative to sensor carrier 402.Sensor carrier 402 may also include, or may itself form, one or moreanchoring features for securing and aligning the analyte sensor duringmanufacturing (e.g., relative to a manufacturing station). Additionally,sensor carrier 402 may include an identifier 450 configured to identifythe sensor. In some embodiments, identifier 450 is formed on substrate404. Identifier 450 will be explained further below.

FIG. 4B illustrates another schematic of a pre-connected analyte sensor400. The pre-connected analyte sensor 400 shown in FIG. 4B may includesimilar components of pre-connected analyte sensor 400 shown in FIG. 4A.FIG. 4B is shown without optional cover 460 for clarity. FIG. 4Cillustrated an exploded view of pre-connected analyte sensor 400 shownin FIG. 4B.

In the example of FIG. 4B, sensor carrier 402 includes an intermediatebody such as a substrate 404, and also includes one or more traces suchas first trace 414 and second trace 416. First trace 414 may include afirst internal contact 406 and a first external contact 410. Secondtrace 416 may include a second internal contact 408 and a secondexternal contact 412. In some embodiments, first internal contact 406 iselectrically coupled to a first contact on a proximal end of sensor 138and second internal contact 408 is electrically coupled to a secondcontact on the proximal end of sensor 138. The distal end of sensor 138is a free end configured for insertion into the skin of the host. Theelectrical coupling is described in connection with various embodimentsherein, such as clips, conductive adhesive, conductive polymer,conductive ink, metallic foil, conductive foam, conductive fabric, wirewrapping, wire threading or any other suitable methods. In someembodiments, a non-conductive adhesive 426 (e.g. epoxy, cyanoacrylate,acrylic, rubber, urethane, hot melt, etc.) can be used to attach thesensor 138 to substrate 404. Non-conductive adhesive 426 may beconfigured to affix, seal, insulate, or provide a strain relief to thesensor 138. Sensor 138 may be attached to substrate 404 by othermethods, such as those described in FIG. 4A above.

As shown in FIG. 4C, a pressure sensitive adhesive 428 may be configuredto isolate an exposed end of traces 414 and 416. For instance, pressuresensitive adhesive 428 may laminate sensor 138 between substrate 404 andcover 460. In such instances, sensor 138, substrate 404, pressuresensitive adhesive 428, and cover 460 may form a laminatedconfiguration. In the laminated configuration, sensor 138 and itsconnection to one or more contacts (e.g. first internal contact 406 andsecond internal contact 408) are isolated from one or more exposedcontacts (e.g. first external contact 410 and second external contact412). Furthermore, the laminated configuration may create a moisturesealed region surrounding the sensor 138. The moisture seal may becreated as embodied by a combination of a pressure sensitive adhesive428 and a non-conductive adhesive 426. In other embodiments, thelaminated structure can be created by one or a combination of thefollowing materials and methods: A non-conductive adhesive, a pressuresensitive adhesive tape, an elastomer, heat bonding, hot plate welding,laser welding, ultrasonic welding, RF welding, or any suitable type oflamination method. The cover 460 may consist of a polymer sheet,structure, or film that at least partially covers the substrate 404. Thecover 460 may optionally contain an identifier 450, which can identifythe sensor 138. In some embodiments, identifier 450 may incorporatevarious identification protocols or techniques such as, but not limitedto, NFC, RFID, QR Code, Bar code, Wi-Fi, Trimmed resistor, Capacitivevalue, Impedance values, ROM, Memory, IC, Flash memory, etc.

Guide fixture 420, which is an optional component, is an exemplaryembodiment of an interface with a work station, such as a testingstation, a calibration station, an assembly station, a coating station,manufacturing stations, or as part of the wearable assembly. The guidefixture 420 includes datum features (or datum structures) 430, such as arecess, an opening, a surface or a protrusion for aligning, positioning,and orienting sensor 138 relative to sensor carrier 402. Datum features430 may be used in manufacturing and for assembly into a wearableelectronic component. In some embodiments, datum features 430 are raisedprotrusions configured to align with corresponding datum features 432 ofsubstrate 404. Corresponding datum features 432 of substrate 404 mayfeature cutouts, slots, holes, or recesses. The corresponding datumfeatures 432 in the sensor carrier may be placement features that caninterface with datum features 430 in a work station, such as a testingstation, a calibration station, an assembly station, a coating station,or other manufacturing stations. Guide fixture 420 may be configured toensure proper placement of the sensor carrier 402 to align the exposedexternal contacts 410 and 412 for connecting to a work station, such asa testing station, a calibration station, an assembly station, a coatingstation, or other manufacturing stations. In other embodiments, datumfeatures 430 may consist of female features to engage with malecorresponding datum features 432.

FIG. 4D illustrates a schematic view of an array 480 of pre-connectedanalyte sensors 400 having a plurality of pre-connected sensors 400 withoptional identifiers 450. In FIG. 4D, an array formed as aone-dimensional strip of pre-connected analyte sensors 400 is shown, buta two-dimensional array could also be implanted. In some embodiments,the array 480 of pre-connected analyte sensors may be disposed in acartridge. Each of the plurality of pre-connected sensors 400 can besingulated. In some embodiments, scoring 4020 may be provided tofacilitate singulation into individual pre-connected sensors 400. Insome embodiments, the array 480 can be used in facilitatingmanufacturing, testing and/or calibrating multiple sensors 138individually in sequential or random manners. In some embodiments, thearray 480 can be used in facilitating manufacturing, testing and/orcalibrating multiple sensors 138 concurrently.

FIGS. 5A-5E show block diagrams of various machines and assemblies thepre-connected analyte sensor 400 may be associated with during itspre-implant lifetime. Such machines and assemblies may includemanufacturing equipment such as one or more manufacturing stations 5091,one or more testing stations 5002 and/or one more calibration stations5004, and an on-skin wearable assembly 600. At least some of these areconfigured to receive sensor carrier 402 and to communicatively couplethe machines and assemblies to sensor 138 via sensor carrier 402.

It is one aspect of some embodiments that the sensor 138 is coupled tothe sensor carrier 402 before the membrane 108 described above isapplied. With the sensor 138 attached to the sensor carrier, andpotentially with multiple carrier mounted sensors attached together asshown in FIG. 4D, subsequent device production steps such as membranecoating, testing, calibration, and assembly into a wearable unit can beperformed with easier mounting and dismounting from manufacturing andtesting equipment, less sensor handling, less chance of damaging themembrane, producing a significant overall improvement in productionefficiency.

Another benefit of the pre-connected sensor construction is that it iseasier to separate different kinds of manufacturing and testing amongdifferent facilities that are better equipped to handle them. Forexample, fabricating the electrodes may require various kinds of metalforming/extrusion machines, whereas membrane application, testing, andcalibration requires a wet chemistry lab and sensitive electronic testequipment. Accordingly, the sensor electrodes may be formed and mountedon the carrier in one facility in one location, and then shipped to adifferent remote facility that is equipped for membrane application,testing, and calibration. Remote in this context means not in the sameproduction facility in the same building. It can even be advantageousfor different commercial entities to perform the different tasks thatspecialize in the appropriate manufacturing and testing technologies.

Manufacturing station 5091 may comprise a testing station as describedherein, a calibration station as described herein, or anothermanufacturing station. Manufacturing station 5091 may include processingcircuitry 5092 and/or mechanical components 5094 operable to performtesting operations, calibration operations, and/or other manufacturingoperations such as sensor straightening operations, membrane applicationoperations, curing operations, calibration-check operations, glucosesensitivity operations (e.g., sensitivity slope, baseline, and/or noisecalibration operations), and/or visual inspection operations.

The pre-connected analyte sensor 400 may be connected to one or moretesting stations 5002 having processing circuitry 5012 configured toperform testing operations with sensor 138 to verify the operationalintegrity of sensor 138. Testing operations may include verifyingelectrical properties of a sensor 138, verifying communication between aworking electrode and contact 408, verifying communication between areference electrode or additional electrodes and contact 406, and/orother electronic verification operations for sensor 138. Processingcircuitry 5012 may be communicatively coupled with sensor 138 fortesting operations by inserting substrate 404 into a receptacle 5006(e.g., a recess in a housing of testing station 5002) until contact 410is coupled to contact 5010 of testing station 5002 and contact 412 iscoupled to contact 5008 of testing station 5002.

System 5000 may include one or more calibration stations 5004 havingprocessing circuitry 5020 configured to perform calibration operationswith sensor 138 to obtain calibration data for in vivo operation ofsensor 138. Calibration data obtained by calibration equipment 5004 maybe provided to on-skin sensor assembly 600 to be used during operationof sensor 138 in vivo. Processing circuitry 5020 may be communicativelycoupled with sensor 138 for calibration operations by insertingsubstrate 404 into a receptacle 5014 (e.g., a recess in a housing ofcalibration station 5004) until contact 410 is coupled to contact 5018of testing station 5002 and contact 412 is coupled to contact 5016 oftesting station 5002.

In the examples of FIGS. 5A-5E, testing station 5002 and calibrationstation 5004 include receptacles 5006 and 5014. However, this is merelyillustrative and sensor carrier 402 may be mounted to testing station5002 and calibration station 5004 and/or manufacturing station 5091using other mounting features such as grasping, clipping, or clampingfigures. For example, manufacturing station 5091 includes graspingstructures 5093 and 5095, at least one of which is movable to graspsensor carrier 402 (or a carrier having multiple sensor carriers andsensors). Structure 5093 may be a stationary feature having one or moreelectrical contacts such as contact 5008. Structure 5095 may be amovable feature that moves (e.g., slides in a direction 5097) to graspand secure sensor carrier 402 in an electrically coupled position formanufacturing station 5091. In other implementations, both features 5093and 5095 are movable.

Sensor carrier 402 may also include an identifier 450 (see, e.g., FIGS.4A-4D). Identifier 450 may be formed on or embedded within substrate404. Identifier 450 may be implemented as a visual or optical identifier(e.g., a barcode or QR code pre-printed or printed on-the-fly onsubstrate 404 or etched in to substrate 404), a radio frequency (RF)identifier, or an electrical identifier (e.g., a laser-trimmed resistor,a capacitive identifier, an inductive identifier, or a micro storagecircuit (e.g., an integrated circuit or other circuitry in which theidentifier is encoded in memory of the identifier) programmable with anidentifier and/or other data before, during, or after testing andcalibration). Identifier 450 may be used for tracking each sensorthrough the manufacturing process for that sensor (e.g., by storing ahistory of testing and/or calibration data for each sensor). In otherwords, the identifier 450 identifies any of the analyte sensor,calibration data for the analyte sensor, and a history of the analytesensor. For example, identifier 450 may be used for binning of testingand calibration performance data. Identifier 450 may be a discrete rawvalue or may encode information in addition to an identification number.Identifier 450 may be used for digitally storing data in non-volatilememory on substrate 404 or as a reference number for storing dataexternal to sensor carrier 402.

Testing station 5002 may include a reader 5011 (e.g., an optical sensor,an RF sensor, or an electrical interface such as an integrated circuitinterface) that reads identifier 450 to obtain a unique identifier ofsensor 138. Testing data obtained by testing station 5002 may be storedand/or transmitted along with the identifier of sensor 138.

Calibration station 5004 may include a reader 5011 (e.g., an opticalsensor, an RF sensor, or an electrical interface) that reads identifier450 to obtain a unique identifier of sensor 138. Calibration dataobtained by calibration station 5004 may be stored and/or transmittedalong with the identifier of sensor 138. In some implementations,calibration data obtained by calibration station 5004 may be added toidentifier 450 by calibration station 5004 (e.g., by programming thecalibration data into the identifier). In some implementations,calibration data obtained by calibration station 5004 may be transmittedto a remote system or device along with identifier 450 by calibrationstation.

As shown in FIGS. 5A-5E and described in further detail hereinafter,on-skin sensor assembly 600 may include one or more contacts such ascontact 5022 configured to couple internal electronic circuitry tocontacts 410 and 412 of sensor carrier 402 and thus to sensor 138.Sensor carrier 402 may be sized and shaped to be secured within a cavity5024 in or on the housing 128 such that sensor 138 is coupled toelectronics in the housing 128 via sensor carrier 402, and sensor 138may be positionally secured to extend from the housing 128 for insertionfor in vivo operations.

Although one calibration station and one testing station are shown inFIGS. 5A-5E, it should be appreciated that more than one testing stationand/or more than one calibration station may be utilized in themanufacturing and testing phase of production. Although calibrationstation 5004 and testing station 5002 are shown as separate stations inFIGS. 5A-5E, it should be appreciated that, in some implementationscalibration stations and testing stations may be combined into one ormore calibration/testing stations (e.g., stations in which processingcircuitry for performing testing and calibration operations is providedwithin a common housing and coupled to a single interface 5006).

Wearable assembly 600 may also include a reader (e.g., an opticalsensor, an RF sensor, or an electrical interface) positioned near thecontacts 5022 that reads identifier 450 to obtain a unique identifier ofsensor 138. Sensor electronics may obtain calibration data for in vivooperation of sensor 138 based on the read identifier 450. Thecalibration data may be stored in, and obtained, from identifier 450itself, or identifier 450 may be used to obtain the calibration data forthe installed sensor 138 from a remote system such as a cloud-basedsystem.

FIGS. 6-8 are schematic illustrations of various implementations ofsecurement of a pre-connected sensor 400 within wearable assembly 600.In the example of FIG. 6 , sensor carrier 402 is in direct contact witha base wall 605 and housing 128, and contact 5022 includes multiplecontacts on the housing 128 for contacting both contacts 410 and 412 ofsensor carrier 402 (e.g., both located on a top surface of sensorcarrier 402). In the example of FIG. 7 , a mechanical receiver 700 isprovided on base wall 605 for mechanically securing sensor carrier 402.In the example of FIG. 8 , mechanical receiver 800 is provided on basewall 605 for mechanically securing sensor carrier 402 in cooperationwith receiver 702. In the example of FIG. 8 , receiver 702 includes anadditional contact 704 for contacting contact 410 of sensor carrier 402located on a rear surface of the sensor carrier.

FIG. 9 shows a detailed example of a sensor module 300 including apre-connected sensor 400 and a sealing structure 192. As shown, sealingstructure 192 may be disposed on a substrate 404, in which sealingstructure 192 may be configured to prevent moisture ingress towardcontacts 410 and 412. Furthermore, contacts 410 and 412 may beimplemented as leaf spring contact for coupling to sensor electronics.In some embodiments, pre-connected sensor 400 includes at least onecontact. In some embodiments, pre-connected sensor 400 includes at leasttwo contacts. In some embodiments, pre-connected sensor 400 includes atleast three contacts. In some embodiments, pre-connected sensor 400includes at least four contacts. An adhesive 126 can couple the housing128 to the skin 130 of the host. The adhesive 126 can be a pressuresensitive adhesive (e.g. acrylic, rubber based, or other suitable type)bonded to a carrier substrate (e.g., spun lace polyester, polyurethanefilm, or other suitable type) for skin attachment. As shown in FIG. 9 ,substrate 404 may include at least one arm 202 or other mechanicalfeatures for interfacing with corresponding mating features on base 128(e.g., mechanical interlocks such as snap fits, clips, and/orinterference features) to mechanically secure substrate 404 to housing128. Coupling features such as arm 902 and/or other features ofsubstrate 404 may be sized and shaped for releasably mechanicallyattaching substrate 404 to a connector associated with manufacturingequipment such as one or more of connectors 5006, 5014, and/or 5093/5095of FIGS. 5A-5E for testing and/or calibration operations duringmanufacturing and prior to attachment to features 900 of housing 128.

FIG. 10 illustrates a perspective view of the sensor module 400 in animplementation in which contacts 406 and 408 are implemented using coilsprings 306. In the example of FIG. 10 , protrusions 308 on substrate404 can align sensor 138 and secure springs 306 to substrate 404. (Notall the protrusions 308 are labeled in order to increase the clarity ofFIG. 10 .) Protrusions 308 can protrude distally.

At least three, at least four, and/or less than ten protrusions 308 canbe configured to contact a perimeter of a spring 306. Protrusions 308can be separated by gaps. The gaps enable protrusions 308 to flexoutward as spring 306 is inserted between protrusions 308. A downwardforce for coupling electronics unit 500 to base 128 can push spring 306against sensor 138 to electrically couple spring 306 to the sensor 138.Sensor 138 can run between at least two of protrusions 308. Testingstation 5002 and/or calibration station 5004 may also have a matingconnector structure that, when substrate 404 is inserted into recess5006 or 5014, compresses springs 306 to couple springs 306 electricallybetween sensor 138 and processing circuitry 5012 or 5020.

Sensor 138 may include a distal portion 138 a configured forsubcutaneous sensing and a proximal portion 138 b mechanically coupledto sensor carrier 402 having an electrical interconnect (e.g., springs306) mechanically coupled to the substrate 404 and electrically coupledto proximal portion 138 b. Springs 306 can be conical springs, helicalsprings, or any other type of spring mentioned herein or suitable forelectrical connections.

Substrate 404 may have a base portion 312 that includes at least twoproximal protrusions 308 located around a perimeter of spring 306.Proximal protrusions 308 are configured to help orient spring 306. Asegment of glucose sensor 138 is located between the proximalprotrusions 308 (distally to the spring 306).

Base portion 312 may be configured to be mechanically coupled to thehousing 128, to manufacturing equipment 5091, testing equipment 5002,and/or calibration equipment 5004. For example, base portion 312includes anchoring features such as arms 202. Anchoring features mayinclude arms 202 and/or may include features such as one or morenotches, recesses, protrusions, or other features in base 312, arms 202,and/or substrate 404 that mechanically interface with correspondingfeatures of, for example, a receptacle such as one of receptacles 5006of 5014 of FIGS. 5A-5E or a clamping connector formed by clampingconnector features such as features 5093 and 5095 of FIGS. 5A-5E tosecure and align sensor 138. In one suitable example, a slidable (orotherwise actuable or rotatable) feature such as feature 5095 of FIGS.5A-5E may be arranged to slide over, around, or otherwise engage withone or more of arms 202, base 312, and/or sensor carrier 402 altogetherto secure sensor carrier 402 to the manufacturing equipment. Forexample, in other implementations of sensor carrier 402 in which arms202 are not provided, a receptacle connector such as one of receptacles5006 of 5014 of FIGS. 5A-5E or a clamping connector formed by clampingconnector features such as features 5093 and 5095 of FIGS. 5A-5E mayinclude a clamshell component, a sliding component, or other movablecomponent that bears against or covers sensor carrier 402 to latchsensor carrier 402 to the manufacturing, testing, and/or calibrationequipment.

Referring now to FIGS. 11 and 12 , another implementation of sensormodule 400 is shown that includes a base portion 312 d; a glucose sensor138 having a distal portion 138 a configured for subcutaneous sensingand a proximal portion 138 b mechanically coupled to base portion 312 d;and an electrical interconnect (e.g., leaf springs 306 d) mechanicallycoupled to substrate 404 and electrically coupled to the proximalportion 138 b. Leaf springs 306 d can be configured to bend in responseto pressure from testing station contacts, calibration station contacts,and/or electronics unit 500 coupling with base 128 while pre-connectedsensor 400 is disposed between electronics unit 500 coupling with base128.

As used herein, cantilever springs are a type of leaf spring. As usedherein, a leaf spring can be made of a number of strips of curved metalthat are held together one above the other. As used herein in manyembodiments, leaf springs only include one strip (e.g., one layer) ofcurved metal (rather than multiple layers of curved metal). For example,leaf spring 306 d in FIG. 11 can be made of one layer of metal ormultiple layers of metal. In some embodiments, leaf springs include onelayer of flat metal secured at one end (such that the leaf spring is acantilever spring).

As shown in FIGS. 11 and 12 , base portion 312 d includes a proximalprotrusion 320 d having a channel 322 d in which at least a portion ofproximal portion 138 b is located. The channel 322 d positions a firstarea of proximal portion 138 b such that the area is electricallycoupled to leaf spring 306 d.

As shown in the cross-sectional, perspective view of FIG. 12 , leafspring 306 d arcs away from the first area and protrudes proximally toelectrically couple with testing station 5002, calibration station 5004,and/or wearable assembly 600. At least a portion of leaf spring 306 dforms a “W” shape. At least a portion of leaf spring 306 d forms a “C”shape. Leaf spring 306 d bends around the proximal protrusion 320 d.Leaf spring 306 d protrudes proximally to electrically couple testingstation 5002, calibration station 5004, and/or electronics unit 500.Seal 192 is configured to impede fluid ingress to leaf spring 306 d.

Leaf spring 306 d is oriented such that coupling sensor carrier 402 totesting station 5002, calibration station 5004, and/or electronics unit500 presses leaf spring 306 d against a first electrical contact of thetesting station 5002, calibration station 5004, and/or electronics unit500 and a second electrical contact of the glucose sensor 138 toelectrically couple the glucose sensor 138 to the testing station 5002,calibration station 5004, and/or electronics unit 500. The proximalheight of seal 192 may be greater than a proximal height of leaf spring306 d such that the testing station 5002, calibration station 5004,and/or electronics unit 500 contacts the seal 192 prior to contactingthe leaf spring 306 d. Springs 306 and/or leaf springs 306 d maycooperate with underlying features on substrate 404 (e.g., features 308)and/or channel 322 d, as shown, to form datum features that secure andalign sensor 138 with respect to sensor carrier 402 (e.g., formanufacturing, calibration, testing, and/or in vivo operations).

FIGS. 13A and 13B show perspective views of an embodiment of a wearableassembly 600 including a pre-connected sensor 400. Wearable assembly 600may include sensor electronics and an adhesive patch (not shown).Pre-connected sensor 400 may include a sensor carrier such as sensorcarrier 402 described in FIGS. 4A-4D. The sensor carrier 402 may beplaced in or on housing 128. Housing 128 may be composed of two housingcomponents, top housing 520 and bottom housing 522. Top housing 520 andbottom housing 522 can be assembled together to form housing 128. Tophousing 520 and bottom housing 522 can be sealed to prevent moistureingress to an internal cavity of housing 128. The sealed housing mayinclude an encapsulating material (e.g. epoxy, silicone, urethane, orother suitable material). In other embodiments, housing 128 is formed asa single component encapsulant (e.g. epoxy) configured to contain sensorcarrier 402 and sensor electronics. FIG. 13A illustrates an aperture 524within top housing 520 configured to allow for an insertion component(e.g. hypodermic needle, C-needle, V-needle, open sided needle, etc.) topass through the wearable assembly 600 for insertion and/or retraction.Aperture 524 may be aligned with a corresponding aperture in bottomhousing 522. In other embodiments, aperture 524 may extend through anoff-center location of housing 128. In other embodiments, aperture 524may extend through an edge of the housing 128, forming a C-shapedchannel. In some embodiments the aperture 524 includes a sealingmaterial such as a gel, adhesive, elastomer, or other suitable materiallocated within aperture 524.

FIG. 13B shows a perspective view of the bottom of wearable assembly600. As illustrated, pre-connected sensor 400 may be disposed within thehousing 128. Pre-connected sensor 400 may be installed within anaperture 526 of bottom housing 522. As shown in the figure, sensor 138may extend out from aperture 526. Aperture 526 may be sized and shapedto retain pre-connected sensor 400. Furthermore, aperture 526 may besized and shaped to retain pre-connected sensor 400 in which sensor 138extends approximately parallel to the skin surface and forms a 90 degreebend for insertion into the skin. It should be understood that thebottom surface of bottom housing 522 can contain an attachment member(e.g. an adhesive patch) for adhering the wearable assembly to the skinsurface of a user.

FIG. 13C shows an exploded view of the wearable assembly 600. Variouselectronic components such as the potentiostat 210 and other componentsillustrated in FIG. 2 may be mounted on or to an electronics assemblysubstrate 530, typically some form of printed circuit board. It iscontemplated that sensor carrier 402 has an electrical coupling withelectronics assembly substrate 530. Various methods may be used toestablish electrical connection (e.g. pins, solder, conductiveelastomer, conductive adhesive, etc.) between one or more contacts ofpre-connected sensor 400, such as external contacts 410 and 412 andelectronics assembly substrate 530. Sensor carrier 402 may be configuredto interface with electronics assembly substrate 530 through the bottomhousing 522. In other implementations, the sensor carrier 402 may beconfigured to interface with the electronics assembly substrate 530through top housing 520. In some other implementations, the sensorcarrier 402 is configured to interface with the electronics assemblysubstrate 530 through the side of wearable assembly 600. Also shown inthe figure, an optional sealing member 528 may be configured to insulateat least a portion of sensor carrier 402 from potential moistureingress. In some instances, the sealing member 528 may be liquiddispensed (e.g., adhesive, gel) or a solid material (e.g., elastomer,polymer). The sealing member 528 may be an assembled component that iswelded (e.g., laser or ultrasonic, hot plate), or otherwise permanentlyattached (e.g., anisotropic adhesive film, pressure sensitive adhesive,cyanoacrylate, epoxy, or other suitable adhesive) to create a sealedregion. The sealing member 528 may be used to physically couple and/orprovide a sealed region for the sensor carrier 402 to the wearableassembly 600.

FIGS. 14A-14E illustrate another implementation of a wearable assembly600. The implementation of FIGS. 14A-14E share some similarities to theimplementation shown in FIGS. 13A-13C. As illustrated in FIG. 14A, thewearable assembly 600 includes a housing formed as a top housing 520 anda bottom housing 522. The wearable assembly also includes a through hole524 for use during interstitial insertion of the sensor 138 into asubject. Referring especially to FIGS. 14B, C, and D, the bottom housing522 includes a recess 726 with a floor 704. The floor 704 may includelocating pins 784 and 786 that extend upward from the floor 704 and twoapertures 722 and 724. The locating pins may be formed as an integralpart of the floor 704, during for example molding of the housing, orthey may be separate parts that are coupled to the floor with frictionfit, adhesive, or any other means. In some embodiments, there is atleast one locating pin. In some embodiments, there are at least twolocating pins. In some embodiments, there are at least three locatingpins. On the opposite side of the floor 704 is a printed circuit board530 (visible in FIG. 14E) with some or all of the sensor electroniccircuitry (e.g. the potentiostat 210 or at least traces that connect tothe potentiostat) mounted thereon. The printed circuit board 530 mayalso have conductive pins 712 and 714 mounted thereon which extendthrough apertures 722 and 724 in the floor 704, forming an externalelectrical interface that is accessible without opening the housing. Thepre-connected sensor 400 drops into this recess 726. Holes 794 and 796drop over locating pins 784 and 786 and conductive pins 712 and 714extend through holes 706 and 708 in the sensor carrier substrate 404.These holes 706 and 708 extend through plated metal (e.g. copper)contacts 406 and 408 on the substrate 404, similar to those shown in adifferent embodiment in FIGS. 4A to 4C. Generally, the number of holes706, 708 in the substrate 404 correspond to the number of electrodespresent in the sensor 138, which may in turn correspond to the number ofpins 712, 714. For example, a three-electrode system with a working,reference, and counter electrode may have three holes in the substratecorresponding to three pins extending up through floor 704. The pins 712and 714 may be electrically connected to the contacts 408 and 406 in avariety of ways such as solder, swaging, or conductive glue, paste,adhesive, or film. After this connection is made, the electroniccircuitry for detecting and/or processing analyte sensor signals that isplaced inside the housing becomes connected to the analyte sensor toreceive signals therefrom. The connection material bonding the sensor138 to the sensor carrier 402 is designated 762 and 764 in FIGS. 14D and14E. These connections may be established by any of the methodsdescribed above with reference to FIG. 4A.

Once the substrate 404 is placed over the pins 712, 714, the proximalportion of the sensor 138 can be secured to the floor 704 with apressure sensitive adhesive 772 to retain the proximal portion of thesensor on or near the housing prior to extending downward at theinserter opening 524. This allows for accurate sensor insertion positionand controls the bias force into the insertion needle. A variety ofmethods and/or structural features may be used to perform this retentionfunction such as a protrusion or shelf in the floor 704, an overmoldedpart, a snap-fit additional plastic piece installed over the sensor, orany sort of glue or adhesive placed before or after the pre-connectedsensor is placed in the recess 726. As is also shown in FIG. 13C,optional sealing members 528 a and 528 b may be configured to seal andinsulate at least a portion of sensor carrier 402 from potentialmoisture ingress. In some instances, the sealing member 528 may beliquid dispensed (e.g., adhesive, gel) or a solid material (e.g.,elastomer, polymer). The sealing member 528 may be an assembledcomponent that is welded (e.g., laser or ultrasonic, hot plate), orotherwise permanently attached (e.g., pressure sensitive adhesive,cyanoacrylate, epoxy, or other suitable adhesive) to create a sealedregion. The sealing member 528 may be used to physically couple and/orprovide a sealed region for the sensor carrier 402 to the wearableassembly 600. The two sealing members 528 a and 528 b are partiallyseparated by walls 766 and 768. These walls allow two different sealingmethods to be used in the two different portions of the recess 726 thatare separated by the walls. For example, 528 b may be a solid polymerthat is press fit into the recess portion with opening 524 on one sideof the walls. The other portion of the recess 726 may then be filledwith a liquid UV cured epoxy which hardens to form sealing member 528 a.The depth of the two recess portions on either side of the walls may bethe same or different.

FIG. 15A shows an alternative embodiment of a sensor carrier 402, alsopotentially taking the form of a printed circuit board. In thisimplementation, a guard trace 407 such as described above with referenceto item 336 in FIG. 3D is provided on the substrate 404 of the sensorcarrier 402. As explained above, this guard trace 407 is positionedbetween contacts 406 and 408 and is connected to the bias voltage by thesensor electronics. The guard trace 407 can be coupled to the sensorelectronics with or more conductive pins 713 (not shown in FIGS. 14A to14E) that extend through the floor 704 similar to pins 712 and 714. InFIG. 15A, the pins are shown connected to castellated contacts on theside of the substrate 404. An insulating layer 780 such as solder maskmay be positioned over the guard trace 407 to eliminate the risk of theanalyte sensor electrodes shorting to it.

FIGS. 15B and 15C illustrated other implementations of connecting asensor carrier 402 having an analyte sensor 138 mounted thereon toelectronic circuitry internal to a wearable sensor. In FIG. 15B, thesensor 138 is coupled to the sensor carrier 402 with conductive adhesive762 and 764 as shown above with reference to FIGS. 14C and 14D. On theother side of the sensor carrier substrate are conductive contact pads812 and 814. The circuit board 530 also has contact pads 826 and 828bonded thereto and which are accessible through the floor 704 of therecess 726. An anisotropic film 820 is used to electrically andmechanically bond the sensor carrier contact 812 to circuit boardcontact 826 and also sensor carrier contact 814 to circuit board contact828. The anisotropic film 820 is compressed with heat between thecontacts, which makes conductive particles in the film 820 bridge thegap vertically between the contact pairs 812/826 and 814/828. Theconductive particles in the film 820 are spaced apart horizontally, sono shorting between the contact pairs occurs. This electrical andmechanical bonding technique has found widespread use in displayapplications for small electronics such as smart phones and lends itselfto easy and consistent connections in production environments.

In FIG. 15C, the proximal region of sensor 138 is coupled to the sensorcarrier 402 contacts 812 and 814 with anisotropic film 820. A differentarea of the same anisotropic film 820 may be used to connect the sensorcarrier contacts 812 and 814 to circuit board contacts 826 and 828respectively. In this implementation, the area of the film 820 thatconnects the sensor 138 to the contacts 812 and 814 may be horizontallyadjacent to or otherwise separated from the area of the film 820 thatconnects the circuit board contacts 826 and 828 to the sensor carriercontacts 812 and 814.

In the examples of FIGS. 10-15 , pre-connected sensor 400 can beinstalled as a standalone interface between sensor 138 and the sensorelectronics. However, it should be appreciated that, in someimplementations described herein, pre-connected sensor 400 may include asensor carrier that couples to an additional interface between thesensor 138 and the sensor electronics inside the wearable assembly 600.For example, channel 322 d and leaf spring 306 d can be formed onseparate substrate that, following calibration and testing operations,mechanically attaches to base portion 312 d within seal 192 forinstallation into wearable assembly 600.

It is one benefit of the analyte sensor connection techniques describedabove that the fabrication of the pre-connected sensor 400 may beseparated from the fabrication of the electronics enclosed within thehousing. As described above with reference to the pre-connected sensorstructure and the subsequent coating, testing and calibrating processes,the housing with the internally contained electronics can bemanufactured in a separate facility from the one that attaches thepre-connected sensor 400 to the sensor electrical interface. This ismade possible by providing an analyte sensor electronics interface thatis accessible from outside the housing. The housing need not be openedto attach the sensor.

In some advantageous methods, the electrodes for the pre-connectedsensor are fabricated and mounted on the substrate in a first locationand are shipped to a second location for coating testing andcalibrating. The housing with internal electronics is manufactured in athird location. The housing with the electronics is shipped from thethird location to the second location, where the completed analytesensor is attached to the external electrical interface. The threelocations can all be remote from each other. This minimizes handling ofthe sensitive membrane coated sensor, but still allows separatemanufacturing of the other components of the complete device.

FIG. 16 shows a top view of an implementation of sensor carrier 402 inwhich substrate 404 is a substantially planar substrate and sensor 138is attached to substrate 404 with a conductive adhesive 1500. As shownin FIG. 16 , conductive adhesive 1500 may be applied to contacts 1000and 1002 of sensor 138 to mechanically attach sensor 138 to substrate404. Once applied the conductive adhesive 1500 on contacts 1000 and1002, may itself form contacts 408 and 406 for coupling to testingstation 5002, calibration station 5004, and/or electronics unit 500.FIG. 17 shows an end view of sensor carrier 402 of FIG. 16 in whichconductive adhesive 1500 can be seen covering a portion of sensor 138 atthe proximal end. In other embodiments, sensor 138 may be attached tosubstrate 404 with a conductive adhesive 1500, or via any other suitablemethods via the use of, for example, clips, conductive polymer, metallicfoil, conductive foam, conductive fabric, wire wrapping, wire threadingor via any other suitable methods.

FIGS. 18, 19, and 20 show examples of substrate 404 of FIG. 16 , withadditional datum features for controlling the position and spatialorientation of sensor 138 on substrate 404. In the example of FIG. 18 ,substrate 404 includes a v-shaped recess 1700. Sensor 138 is disposedpartially within recess 1700 to orient sensor 138 in a direction alongthe recess, and conductive adhesive 1500 substantially covers sensor 138and fills in portions of recess 1700 not filled by sensor 138 to securesensor 138 within the recess. In the example of FIG. 19 , substrate 404includes a first planar portion 1800 and a second planar portion 1802extending at a non-parallel (e.g., perpendicular) angle with respect tothe first planar portion, and sensor 138 is attached at the interface ofthe first and second planar portions by conductive adhesive 1500. In theexample of FIG. 20 , substrate 404 includes a rounded recess 1900 inwhich sensor 138 is attached by conductive adhesive 1500 thatsubstantially covers sensor 138 and fills in portions of recess 1700 notfilled by sensor 138 to secure sensor 138 within the recess.

FIGS. 21A and 21B show an example sensor carrier 402 with at least onepair of guide structures 2106 and 2108 formed on the substrate 404, suchas on one or both contacts 406 and 408. These guide structures canassist placement of the sensor body 138 on the appropriate location whenapplying conductive adhesive to bond the two together. This caneliminate the need for external guide fixtures when assembling thesensor to the sensor carrier during manufacturing. The structures 2106,2108 can be made of solder or other conductive adhesive. Although notshown in FIGS. 21A and 21B, an additional adhesive bonding material canbe provided between the guide structures to fix the sensor to the guidestructures during manufacturing.

Conductive adhesive 1500 may be, for example, a conductive liquiddispensed glue. The conductive liquid dispensed glue may be a one ortwo-part adhesive that cures (e.g., at room temperate or an elevatedcuring temperate). The conductive liquid dispensed glue may be asnap-cure adhesive. A two-part conductive liquid dispensed glue mayinclude a base adhesive (e.g., epoxy, polyurethane, etc.) and aconductive filler (e.g., silver, carbon, nickel, etc.). Conductiveadhesive 1500 may include, for example, an adhesive resin with one ormore embedded conductive materials such as silver, copper or graphite.Conductive adhesive 1500 may be a heat curable conductive adhesive.

FIG. 22 shows a top view of an implementation of sensor carrier 402 inwhich substrate 404 is a substantially planar substrate and sensor 138is attached to substrate 404 with a conductive tape 2000. As shown inFIG. 22 , conductive tape 2000 may be applied to one or more contacts(e.g. connection areas 1000 and 1002) of sensor 138 to mechanicallyattach sensor 138 to substrate 404. Once applied the conductive tape2000 on contacts 1000 and 1002, may itself form contacts 408 and 406 forcoupling to testing station 5002, calibration station 5004, and/orelectronics unit 500. Tape 200 may be applied over sensor 138 as shownin FIG. 22 , or may be interposed between substrate 404 and sensor 138.In implementations in which tape 2000 is disposed between substrate 404and sensor 138, substrate 404 may be a flexible substrate that can berolled or folded around sensor 138 as shown in the end view of FIG. 23 .The rolled substrate of FIG. 23 includes extending portions 2100 thatcan form one or more contacts (e.g. 406 or 408).

Conductive tape 2000 may be configured for use as a multi-zoned tapewith one or more conductive tapes 2000 and non-conductive tape sections.The combination of conductive and non-conductive regions can be used toelectrically isolate connection regions. Using a multi-zoned tape maysimplify the assembly of multiple connection regions in a singleassembly step. The pitch of the conductive regions on the tape may bematched to the targeted connection area of the sensor wire 138. In otherembodiments the pitch of the conductive region of the tape issignificantly less than the spacing of the targeted connection area ofthe sensor wire 138. A shorter pitch may allow for more variability intape placement while ensuring isolated connection between the sensor 138and the substrate 404. Conductive tape 2000 may be formed from a polymersubstrate with a conductive adhesive (e.g. carbon-impregnated adhesive,metal-impregnated adhesive). As another example, conductive tape 2000may be a metallic substrate with conductive and non-conductive adhesive.Some examples of non-conductive substrates are polyimide, composite,polymers, etc. Some examples of conductive substrates are metals (e.g.Foils, plating, cladding, etc), conductive polymers, and conductiveelastomers. Examples of non-conductive adhesive are epoxy,cyanoacrylate, acrylic, rubber, urethane, hot melt, etc. Examples ofconductive adhesives are carbon filled adhesive, nano particle filledadhesive, metal filled adhesive (e.g. silver), conductive inks, etc.

FIG. 24 shows a top view of an implementation of sensor carrier 402 inwhich substrate 404 is a substantially planar substrate and sensor 138is attached to substrate 404 with a conducive plastic 2200 welded orbonded to a non-conductive (e.g., plastic) substrate 404. As shown inFIG. 24 , conductive plastic 2200 may be applied to contacts 1000 and1002 of sensor 138 to mechanically attach sensor 138 to substrate 404.Once applied the conductive plastic 2200 on contacts 1000 and 1002, mayitself form contacts 408 and 406 for coupling to testing station 5002,calibration station 5004, and/or electronics unit 500.

FIGS. 25 and 26 show an exemplary ultrasonic welding system for weldingconductive plastic 2200 to substrate 404. As shown in FIG. 25 ,substrate 404 may be provided with a recess within which a protrusion ona conductive plastic member 2200 can be received. Sensor 138 may bedisposed within a recess in the protrusion on conductive plastic member2200 and conductive plastic member 2200 can be pressed in direction 2302and vibrated by ultrasonic welding horn 2300 to form a melt region 2400that, when horn 2300 is removed, solidifies to secure sensor 138 betweensubstrate 404 and conductive plastic 2200 to form a conductive contactto sensor 138.

In some implementations, in order to provide a sensor 138 withadditional surface area for clipping or soldering of contacts tosubstrate 404, the proximal end of sensor 138 may be rolled or otherwiseflattened as shown in FIG. 27 . As shown in FIG. 27 , contacts 1000F and1002F may be flat contacts that converge into a cylindrical wire sensor138. As shown in the side view of sensor carrier 402 in FIG. 28 ,flattened contacts 1000F and 1002F may be attached to substrate 404 withconductive attachment members 2600 and 2602 such as clips, solder welds,an anisotropic conductive film, a conductive tape, a plastic member withembedded conductors, conductive springs, or elastomeric conductivemembers (as examples).

In one example, connectors such as contacts 1000F and 1002F (and/orother forms of contacts 1000 and 1002 described herein) may be lasersoldered to corresponding contacts on substrate 404. In implementationsin which sensor 138 is laser soldered to substrate 404, a trace surfaceof substrate 404 may be preheated by laser illumination at a solderinglocation. The surface heat emission may reflow a pre-deposited soldermaterial on either side of sensor 139. A guide such as a borosilicateglass “angle” may be placed over the sensor and per-deposited solder toretain the solder, driving molten solder towards the sensor. A resulting“cradle” bond may then securely anchor the sensor to the trace onsubstrate 404 which may help increase or maximize atrace-to-solder-sensor contact wire bonding area. Use of a guide such asa borosilicate glass angle may also protect printed circuit boardassembly electronics that may be included on and/or in the substratefrom solder debris during the hot portion of the soldering process.

In another example, connectors such as contacts 1000F and 1002F (and/orother forms of contacts 1000 and 1002 described herein) may be solderedto corresponding contacts on substrate 404 without a laser. In theseexample, solder wire may be pre-fed onto a tip of a soldering iron tobuild up a blob of molten solder on the tip. The iron may then be moveddown so the blob touches the sensor and conductive trace on thesubstrate. A coating on the sensor such as the Ag/AgCl coating describedherein may be provided with a low thermal mass such that the sensorcoating heats up quickly without freezing the solder. Once the coatingis heated, the solder wets to the coating. The trace would also haveminimal thermal mass so it will heat up quickly without freezing thesolder. A solder mask may be provided around the trace that prevents thesolder flowing off the edge of the trace.

In some implementations, substrate 404 may be formed, at least in part,by a flexible circuit (e.g., a polyimide substrate having conductivetraces or other suitable flex circuit) that folds over and/or around atleast a portion of sensor 138 to conductive traces of the flex circuit.FIG. 29 shows a top view of a flex circuit implementation of substrate404 in which substrate 404 is a flexible circuit having a central,non-conductive, elongated portion 2702 along which sensor 138 isoriented and having upper and lower extensions 2700 and 2704 that extendfrom central portion in a directed perpendicular to the elongateddimension of central portion 2702. Extensions 2700 and 2704 respectivelyinclude conductive contacts 2706 and 2708 that form contacts 408 and406. Conductive contacts 2706 and 2708 may be coupled, via traces and/orconductive vias on or within substrate 404 to external contacts thatform contacts 412 and 410. In some instances, extensions 2700 and 2704may allow for testing, calibration, sensor electronics or otherequipment to connect to sensor carrier/sensor assembly in area that isnot occupied by the sensor. This may allow for additional connectiontypes and/or improve electrical coupling of connection.

FIG. 30 shows an implementation of sensor carrier 402 in which substrate404 includes a wedge-shaped base portion 2800 and a foldable flexibleportion 2802. Conductive contacts 2804 may extend from base portion 2800to foldable portion 2802 so that, when sensor 138 is placed on baseportion 2800 and optionally foldable portion 2802 is be folded oversensor 138 (e.g., in direction 2820) to wrap over and around sensor 138,contacts 410 and 412 electrically couple to sensor 138. Base portion2800 may be rigid and may taper in a direction away from sensor 138.Base portion 2800 may include conductive contacts 410 and 412 at anarrow end. Base portion 2800 may, for example, be removably insertedinto recesses 5006 and 5014 of testing station 5002 and calibrationstation 5004 for testing and calibration operations. In the examples ofFIGS. 27 and 28 , the flexible substrate may be folded over the sensorand secured (e.g., to the sensor and/or to itself to secure the sensorby a welding soldering, a mechanical crimp, spring contacts, rivets,adhesive such as epoxies, or the like.

FIGS. 31A and 31B illustrate another embodiment of a sensor carrier 402.In this embodiment, the sensor carrier 402 comprises a block 404 made ofnon-conducting material such as a polymer or ceramic. The block 404includes a through-hole 1420 extending therethrough along the y-axisthrough which the proximal ex vivo portion of the analyte sensor 138extends. Slots or blind holes 1410 and 1412 intersect the through-hole1420 on an orthogonal z-axis to the through hole y-axis. Conductivecontact material 406 and 408 is plated on the top surface and extendsinto the slots 1410 and 1412. Additional holes 1430 and 1432 extendingalong the x-axis intersect both the through-hole 1420 and the slots 1410and 1412. Each hole 1430 and 1432 extends across its respective slot andpartway into the block on the other side of each slot forming a blindhole or depression 1442, 1444 on the other side. Plugs 1451 and 1453,which may be conductive or non-conductive are inserted into the holes1430 and 1432 and push the contacts 212 b and 211 b of the wire analytesensor into the depressions 1442, 1444, causing the contacts 212 b and211 b to come into electrical contact with the sensor carrier contacts406 and 408.

FIG. 32 shows a top view of a sensor carrier having a substrate 404, adatum feature 2900, and a movable connector 2902 for each of contacts406 and 408. Sensor 138 may be aligned against datum features 2900 andmovable connectors 2902 may be moved to secure each of contacts 1000 and1002 between the corresponding datum feature and movable connector.Movable connectors 2902 and/or datum features 2900 conductively coupleto contacts 1000 and 1002. Movable connectors 2902 and/or datum features2900 may be conductively coupled to other contacts (not shown) onsubstrate 404 that form contacts 410 and 412. FIG. 33 is a perspectiveview of one of datum features 2900 and an associate movable contact2902, movable in a direction 2904 toward datum feature 2900 to securesensor 138. Contacts 1000 and 1002 may be flattened to enhance contactwith datum feature 2900 and contact 2902. Additional conductive material2906 may be formed on substrate 404 between datum feature 2900 andcontact 2902 to enhance electrical contact with sensor 138 if desired.The additional conductive material may be an exposed surface of aportion of an embedded conductive layer (e.g., a copper or otherconductive metal layer) within substrate 404 or may be solder or aconductive adhesive (as examples).

FIG. 34 shows a perspective view of a pre-connected sensor formed from asensor carrier implemented as a barrel connector that substantiallysurrounds sensor 138. In the example of FIG. 34 , substrate 404 may bean insulating layer formed around sensor 138 with conductive bands thatextend from an internal contact with contacts 1000 and 1002 to anexternal surface that forms contacts 410 and 412. As shown in FIG. 34 ,annular contacts 410 and 412 may be removable received by a press fitinto conductive brackets 3102 and 3104 of a device 3100 (e.g., testingstation 5002, calibration station 5004, and/or electronics unit 500).Conductive brackets 3102 and 3104 may establish electrical communicationbetween sensor 138 and device 3100 (e.g., testing station 5002,calibration station 5004, and/or electronics unit 500).

FIG. 35A shows an implementation of sensor carrier 402 in which aflexible circuit is wrapped over an end of sensor 138 such that a topportion 3200 and a bottom portion 3202 of the flexible substrate areformed on opposing sides of sensor 138. As shown in FIG. 35B, topportion 3200 and bottom portion 3202 may be wrapped over the ends ofmultiple sensors 138 such that a flex circuit strip 3404 forms a commonsensor carrier for multiple sensors. Flex circuit strip 3204 may includepairs of internal contacts for coupling to contacts 1000 and 1002 ofeach sensor 138 and pairs of external contacts, each pair of externalcontacts coupled to a corresponding pair of internal contacts andforming contacts for coupling to testing station 5002 and/or calibrationstation 5004. In this way, multiple sensors can be transported andcoupled to testing and calibration equipment as a group. Strip sensorcarrier 3204 may include identifiers for each sensor 138 so that testingand/or calibration data for each sensor can be logged and stored.Individual pre-connected sensors may be formed by singulating stripsensor carrier 3204 into individual sensor carriers for each sensor thatcan be installed in an electronics unit, such as the wearable sensorunits of FIGS. 13 and 14 . Strip 3204 may include singulation features3220 (e.g., markings and/or scoring that facilitate singulation intoindividual pre-connected sensors.

Although FIGS. 35A and 35B show a flexible circuit strip that is wrappedaround the ends of sensor 138, this is merely illustrative. It should beappreciated that a flex strip carrier for more one or more sensors 138may be attached to the sensor(s) in other ways. For example, the ends orother portions of sensors 138 may extend into a substrate of flexiblecircuit strip 3204 to couple to internal conductive contacts in thestrip or the ends or other portions of sensors 138 may be attached to asurface of flexible circuit strip 3204 (e.g., using an anisotropicconductive film (ACF) or other conductive adhesive, a laser solder orother solder, a clip or other attachment mechanisms and/or datumfeatures that position and align the sensor).

FIG. 36 shows an implementation of sensor carrier 302 in which a crimpconnector 3301 extends through a portion of substrate 404. As shown inFIG. 36 , crimp connector 3301 may have a base portion 3300 that extendsfrom a first side of substrate 404 (e.g., to form one of contacts 410and 412). Crimp connector 3301 also includes arms 3302 extend from anopposing second side of substrate 404. As shown in FIG. 37 , arms 3302can be pressed together or crimped to mechanically secure andconductively couple to sensor 138, thereby forming, for example, contact406. FIG. 38 shows a side view of the sensor carrier of FIGS. 36 and 37and shows how two crimp connectors may be provided that extend throughsubstrate 404 and form contacts 406 and 408 on a first side and contacts410 and 412 on a second side. Although contacts 410 and 412 are formedon the second side of substrate 404 in FIG. 38 , it should beappreciated that contacts 410 and 412 can be formed on the first side,or on a sidewall or edge of substrate 404 (e.g., by including one ormore bends or other conductive couplings within substrate 404).

FIG. 39 shows an implementation of pre-connected sensor in which sensorcarrier 402 includes a distally oriented channel 358 that directs sensor138 distally such that sensor 138 includes a bend that is at least 45degrees and/or less than 135 degrees. A channel cover 362 secures theglucose sensor 138 in the distally oriented channel 358. In the exampleof FIG. 39 , one or more contacts (e.g. 408 and 406) are implementedusing conductive elastomeric members 1400. In other embodiments contactsmay be any suitable type (e.g. coil springs 306, leaf spring 306 d).Contacts (e.g. conductive elastomeric members 1400) form a conductivecoupling between sensor 138 and external equipment (e.g., testingstation 5002, calibration station 5004, and/or on-skin sensor assembly600). Contacts may cooperate with underlying features on substrate 404(e.g., protrusions 308) and/or channel 322 d, as shown, to form datumfeatures that secure and align sensor 138 with respect to sensor carrier402 (e.g., for manufacturing, calibration, testing, and/or in vivooperations). In some implementations, the sensor 138 maybe bent, glued,or bonded so as to be affixed within sensor carrier 402.

FIG. 40 shows an implementation of sensor carrier 402 in which substrate404 is a molded interconnect device. In the example of FIG. 40 ,substrate 404 is formed from molded thermoplastic or thermoset (e.g.,acrylonitrile butadiene styrene, a liquid crystal polymer, apolyimide/polyphthalamide plastic, or other thermoplastic or thermosetpolymer materials) that includes conductive traces 3702. Conductivetraces 3702 may be formed on a surface of substrate 404 and/or may passinto and/or through portions of substrate 404 to form suitableconnections. Conductive traces may be formed on the molded substrateusing a variety of techniques (e.g. selective plating via laser etching,combining platable and non platable substrate polymers, or othersuitable methods). In other embodiments, a conductive material (e.g.conductive polymer, metal stamping, plated polymer, metallic structure)may be overmolded with a non-conductive material.

To create suitable electrical connections as shown in FIG. 40 ,conductive traces 3702 are electrically coupled between contacts (e.g.contact region 1000 and 1002 on sensor 138) and external contacts (e.g.contacts 410 and 412). Although contacts (e.g. 410 and 412) are formedon the same surface of substrate 404 to which sensor 138 is attached inthe example of FIG. 37 , this is merely illustrative. It should beappreciated that contacts (e.g. contacts 410 and 412) may be formed onan opposing surface or on an edge or sidewall of substrate 404 andcoupled to contacts (e.g. contacts 408 and 406) by conductive materials(e.g. conductive layers, structures, adhesive, clips, solder, orinterconnects) within or on substrate 404. For example, contacts (e.g.contacts 410 and 412) may form a designated area to interface electricalcoupling on a different surface or region of substrate 404 on whichsensor 138 is attached. The designated area may form a channel, groove,recess, slot, or similar alignment feature for orienting the sensor.

Molded thermoplastic substrate 404 may be an injection-molded substratehaving features that facilitate various aspects of testing, calibration,and wearable device installation for sensor 138. For example, moldedthermoplastic substrate 404 may include datum features or other locatingfeatures or positioning features such as a recess 3700 having a shapethat is complementary to the shape of the proximal end of sensor 138.For example, recess 3700 may include three or more stepped regions thatcorrespond to the steps between the different layers of the coaxialanalyte sensor such as shown in FIG. 3D. In other configurations, moldedthermoplastic substrate 404 may include a flat-walled recess as in theexample of FIG. 18 , a wall that forms a corner as in the example ofFIG. 19 , or a rounded recess as in the example of FIG. 20 . In yetother configurations, molded thermoplastic substrate 404 may includeraised features or protrusions on the surface that position and alignsensor 138. For example, a raised channel having a shape correspondingto the shape of sensor 138 may be provided on the surface of moldedthermoplastic substrate 404. As another example one more posts mayextend from the surface of molded thermoplastic substrate 404. Forexample, one or more lines of protrusions can be formed on the surfaceof molded thermoplastic substrate 404 against which and/or between whichsensor 138 can be positioned and aligned. In this way, variousconfigurations can be provided for a molded thermoplastic substrate 404including datum features that orient sensor 138 in a preferred directionat a preferred position.

Molded thermoplastic substrate 404 may also include other shapedfeatures such as finger holds 3720 on opposing sides the substrate thatfacilitate grasping, holding, and transporting of sensor 138. Moldedthermoplastic substrate 404 may also include other shaped features suchas anchoring features corresponding to the shape of connectors formanufacturing equipment 5091, testing equipment 5004, and calibrationequipment 5004 such as grasping connector features 5093/5095 ofmanufacturing equipment 5091 and/or recess connectors 5006 and 5014 oftesting equipment 5002 and calibration equipment 5004. Anchoringfeatures formed on molded thermoplastic substrate 404 and/or by moldedthermoplastic substrate 404 itself may include one or more protrusionssuch as posts, snap-fit features, arms such as arms 202 (see, e.g.,FIGS. 11-14 ), recesses, notches, hooks, and/or tapered portions similarto the tapered portions shown in FIG. 28 (as examples). In someexamples, a portion of molded thermoplastic substrate 404 or the entiremolded thermoplastic substrate 404 may have a shape that corresponds tothe shape of a mounting receptacle on or within one or more ofmanufacturing equipment 5091, testing equipment 5002, calibrationequipment 5004, carriers, and/or a wearable device.

Although substrate 404 is shown in FIG. 40 as being substantiallyrectilinear, a molded thermoplastic substrate 404 can be provided withfeatures 3720 and/or an overall shape such as a handle shape forinserting, pulling, or otherwise manipulating sensor 138 duringmanufacturing and assembly operations. For example, molded thermoplasticsubstrate 404 may include a main portion configured to mechanically andelectrically interface with manufacturing equipment 5091, testingequipment 5002, calibration equipment 5004, and/or a wearable device,and a gripping portion that extends from the main portion. The grippingportion may extend from the manufacturing equipment 5091, testingequipment 5002, or calibration equipment 5004 during manufacturingoperations to facilitate removal of sensor carrier 402 and sensor 138from the equipment after or between the manufacturing operations. Thegripping portion may be integrally formed with the main portion or maybe a separate component that extends from the surface of, or fromwithin, molded thermoplastic substrate 404. The gripping component maybe a post, a stock, a shaft, or an arched handle shaped for gripping bya gripping tool or by hand (e.g., by a technician).

As shown in FIG. 40 , sensor 138 may be placed in recess 3700 andsecured to substrate 404 using adhesive 3704 (e.g., a conductiveadhesive as described herein). Adhesive 3704 may be applied to couplecontact 1000 of sensor 138 to a first conductive trace 3702 on substrate404 to form contact 408 between sensor 138 and sensor carrier 402.Adhesive 3704 may be also applied to couple contact 1002 of sensor 138to a second conductive trace 3702 on substrate 404 to form contact 406between sensor 138 and sensor carrier 402. In this way, moldedthermoplastic substrate 404 can provide a handle and/or a strain reliefmember for moving and/or otherwise handling sensor 138.

FIG. 41 shows a top view of sensor carrier 402 of FIG. 40 . As shown inFIGS. 40 and 41 , the first conductive trace 3702 may extend from acontact portion with contact 1000 within recess 3700 to form one or moreexposed portions on the surface of substrate 404 that form externalcontact 412 for coupling to testing station 5002, calibration station5004, and/or electronics unit 500. The second conductive trace 3702 mayextend from a contact portion with contact 1002 within recess 3700 toform one or more exposed portions on the surface of substrate 404 thatform external contact 410 for coupling to testing station 5002,calibration station 5004, and/or electronics unit 500.

FIG. 42 shows a specific implementation of sensor carrier 402 asillustrated in FIGS. 40 and 41 . In this implementation of sensorcarrier 402, sensor 138 is attached to substrate 404 with a conductivecoupler 3900, such as, for example, clips, conductive adhesive,conductive polymer, metallic foil, conductive foam, conductive fabric,wire wrapping, wire threading or via any suitable methods. As shown inFIG. 43 , a substrate 4000 may have an elongated dimension along whichparallel conductive strips 4001 and 4002 are formed. Multiple sensor 138may be attached to substrate 4000 and extend beyond an edge of thesubstrate in a direction perpendicular to the elongated dimension of thesubstrate. Singulation features such as scoring 4020 may be providedthat facilitate singulation of substrate 4000 into individual sensorcarrier substrates 404 for each sensor and/or that electrically isolateportions of conductive strips 4001 and 4002 for each sensor. Each sensormay be attached to substrate 4000 using, for example clips 3900 or anyother methods including, via the use of conductive adhesive, conductivepolymer, metallic foil, conductive foam, conductive fabric, wirewrapping, wire threading or any other suitable methods. An identifier450 for each sensor may be provided on a corresponding portion ofsubstrate 4000.

Sensors 138 may each have a pair of sensor electrical contacts (e.g.,contacts 1000 and 1002) coupled to a corresponding pair of electricalcontacts formed from strips 4001 and 4002 on the substrate. Openings insubstrate 4000 and/or vias that extend through substrate 4000 mayprovide exposed portions of strips 4001 and 4002 that form a pluralityof pairs of electrical contacts for coupling each sensor 138 to testingstation 5002, calibration station 5004, and/or electronics unit 500(e.g., an electronics unit of a wearable device). Each of the pluralityof pairs of electrical contacts is coupled to an associated pair ofportions of strips 4001 and 4002 via the substrate.

FIGS. 44-46 show various contact configurations on sensor carriers thatcan be singulated from a sensor carrier strip of the type shown in FIG.43 . In the example of FIG. 44 , a z-shaped contact configuration onsubstrate 4000 has been singulated to form a pre-connected sensor on asmaller portion of the substrate, referred to as substrate 404. In thisinstance, the z-shaped contact configuration may allow for greaterdistance between connectors (e.g., larger pitch connection) on testing,manufacturing, or calibration equipment, though a z-shaped substrate isnot necessary to generate the greater distance and other substrateshapes can be used. In the example of FIG. 45 , a square portion ofsubstrate 4000 has been singulated to form a pre-connected sensor on thesubstrate 404. In the example of FIG. 46 a square portion of substrate4000 has been singulated to form a pre-connected sensor and an opening4300 (e.g., an air gap) is provided in the singulated substrate 404 toimprove electrical isolation between singulated contact strip portions4001 and 4002.

As shown in FIG. 47A, in some implementations, an elongate substrate4000 that forms a sensor carrier for multiple sensor 138 can be providedwith a feed-guide strip 4402 that runs along an elongated edge of theelongate substrate. Feed-guide strip 4402 may include locating features4404 that can be accessed and manipulated to move and register a stripof pre-connected sensors through one or more manufacturing stations.

In the implementation of FIG. 47A, sensors 138 can be attached tosubstrate 4000 in bulk and singulated on substrate 404 aftermanufacturing or testing operations. As shown in FIG. 47B, a strip ofpre-connected sensors as shown in FIG. 47A can be provided on a reel4410 for bulk storage and/or transportation and optionally automaticallypulled from the reel using feed-guide strip 4402 to be moved through oneor more testing stations and/or one or more calibration stations. FIG.48 shows a pre-connected sensor having a sensor carrier that has beensingulated from substrate 4000 and separated from a singulated portion4402 of feed-guide strip 4402. Alternatively, feed-guide strip 4402 canbe separated as a strip prior to singulation of individual pre-connectedsensors. In other embodiments, the feed guide is integrated into thefinal product configuration and not removed from the sensor carrierduring or after singulation.

FIG. 49 shows an implementation of sensor carrier 402 in which aplurality of sets of contacts 406 and 408 are formed from receptacles4600 having a slot for receiving a corresponding plurality of sensors138. In some implementations, the receptacles 4600 may be an elongatedmember comprising a resilient or flexible material. The receptacles 4600may have slots that optionally pierce through an insulation layer ordeform a portion of the outer layer so as to make contact with thesensors 138.

FIG. 50 shows an implementation of a sensor carrier for multiple sensors138 having recesses 4700 that form datum features to hold each sensor inan accurate alignment and position. Complementary magnetic features maybe provided on sensor 138 and substrate 404 to hold each sensor in anaccurate alignment and position and thereby facilitate accurate sensorprocessing.

FIG. 51A shows an implementation of an elongate substrate 4800 formedusing printed circuit board technology from either a rigid, flexible, ora combination rigid/flexible substrate, from which multiple sensorcarriers 402 can be singulated. Flexible portion of the substrate may bemanufactured from a material such as polyimide, PEEK, polyester or anysuitable type. Rigid portion of the substrate may be manufactured from amaterial such as FR4, FR5, FR6, insulated metal substrate (IMS), PTFE,or any suitable type. As shown in FIG. 51A, each sensor carrier mayinclude a sensor connection portion 4804 and an interface or processingportion 4802. In some implementations, each sensor carrier may include asensor connection portion 4804 that extends from a rigid or flexibleportion and an interface or processing portion 4802 that extends from arigid or flexible portion. In these implementations, one or morecontacts, such as contacts 406 and 408 can be formed on the sensorconnection portion 4804 of each sensor carrier 402. Sensor connectionportions 4804 of substrate 4800 may contain anchoring or datum featuresof sensor carriers 402.

FIG. 51B shows another implementation of an elongate substrate 4800 asshown in FIG. 51A with an optional electrical connection interface 4850for connecting to a work station, such as a testing station, acalibration station, an assembly station, a coating station, or othermanufacturing stations. The optional electrical connection interface4850 may be coupled to one or more sensor carriers 402 throughelectrical traces configured on one or more layers of the circuit board.As shown in FIG. 51B, a plurality of sensor carriers 402 are assembledin a panel, and each of the sensor carrier 402 may include a sensorconnection portion 4804 that extends from a flexible or rigid portionand an interface or processing portion 4802 that extends from a flexibleor rigid portion. In these implementations, one or more contacts, suchas contacts 406 and 408 can be formed on the sensor connection portion4804 of each sensor carrier 402. Sensor connection portions 4804 ofsubstrate 4800 may contain anchoring or datum features of sensorcarriers 402. In some implementations, the elongate substrate 4800 shownin FIG. 51B may be configured to allow the sensor 138 to extend beyondthe edge of the substrate. This may be accomplished by removing aportion of the elongated substrate 4860 for further processing. In someembodiments a perforation (e.g. V-score, mouse bites, or other suitabletype) is included in elongated substrate 4800 for enabling the removalof the bottom portion of the panel 4860 for dipping or calibration. Inthis implementation, the elongated substrate 4800 can be configured fordipping or calibration, as described in FIG. 52B.

Now referring to FIG. 52A, an implementation of a sensor carrier 402 isshown with one or more sensor contacts (e.g. contacts 406 and 408) onsensor connection portion 4804 and one or more one or more interfacecontacts (e.g. contacts 410 and 412) on an interface or processingportion 4802. One or more interface contacts (e.g., 410 and 412) may beformed on sensor carrier 402 for coupling to testing station 5002,calibration station 5004, and/or electronics unit 500. In thisconfiguration, testing and/or calibration operations can be performed bycoupling portion 4802 to the testing and/or calibration equipment.

FIG. 52B shows an example panel implementation of a plurality of sensorcarriers 402 with electrical connection interface 4850 for interfacingwith electronics of a work station, such as a testing station, acalibration station, an assembly station, a coating station, or othermanufacturing stations. The illustration of FIG. 52B shows the elongatesubstrate 4800 of FIG. 48B after the bottom panel portion 4860 has beenremoved (from the illustration of FIG. 51B) and with sensor 138 attachedvia one or more sensor contacts (e.g. contacts 406 and 408). In someimplementations, the sensors can be permanently connected (e.g.conductive adhesive, conductive polymer, conductive ink, solder,welding, brazing, or other suitable methods) to the sensor carriers 402and both components can be calibrated together or separately. In otherimplementations, the sensors can be releasably attached (e.g. via clips,metallic foil, conductive foam, conductive fabric, wire wrapping, wirethreading or any other suitable methods).

Following testing and/or calibration operations, flexible portion 4802may be folded around, folded over, wrapped around, wrapped over, ormanipulated to envelope portion 4804 for installation into on-skinsensor assembly 600. In the example of FIG. 53A, portion 4802 may form astandalone processing circuit for sensor 138 (e.g., an implementation ofsensor electronics 112. In other implementations, portion 4802 may becoupled directly to signal processing circuit for assembly 600, to asystem in package (SIP) implementation of the sensor electronics or amain printed circuit board for the sensor electronics. In the example ofFIG. 53B, the flexible portion 4804 is folded to envelope portion 4802for installation into on-skin sensor assembly 600 so as to have sensor138 positionally secured to extend (e.g. through opening 4808) forinsertion for in vivo operations.

FIG. 54 shows an implementation in which sensor carrier 402 ismanufactured using printed circuit board technology as a daughter boardfor a main printed circuit board 5100 for the sensor electronics. Asshown in FIG. 54 , one or more contacts such as contacts 5104 (e.g.,solder contacts) may be formed between sensor carrier 402 and main PCB5100 to form sensor electronics unit for sensor 138 in on-skin sensorassembly 600. Conductive traces 5102 may couple contacts 5104 to sensor138 via a conductive attachment mechanism 5103 (e.g., solder, conductiveadhesive, a conductive tape, or other conductive attachment as discussedherein).

FIG. 55 shows an implementation of sensor carrier 402 in which a pinchclip 5200 is provided to close the arms 5204 of a crimp connector 5202to secure sensor 138 to substrate 404. Connector 5204 may be formed forma conductive material that forms one of contacts 410 and 412. As shownin FIG. 55 , pinch clip 5200 includes clasping arms 5208 with rampedsurfaces that push the arms outward as pinch clip 5200 is move towardsubstrate 404 in direction 5206 and snap back to secure pinch clip 5200to substrate 404. In other implementations, pinch clip 5200 may beprovided without clasping arms 5208 so that pinch clip 5200 is removableafter arms 5204 are pinched closed so that pinch clip 5200 does not forma part of the sensor carrier. As shown in FIG. 55 , one or moreelectrode breakouts 5220 may be provided to form, for example, one ormore of contacts 410 and 412 on substrate 404. Although breakout 5220 isformed on a surface of substrate 404 that is opposed to the surface towhich sensor 138 is attached in the example of FIG. 55 , this is merelyillustrative. It should be appreciated that breakouts for contacts suchas contacts 410 and 412 may be formed on the opposing surface, on thesame surface as sensor 138, or on an edge or sidewall of substrate 404and coupled to contacts 408 and 406 by conductive vias or otherconductive layers, structures, or interconnects within or on substrate404. In some implementations, a pinch clip 5200 may be used to applybias force against sensor 138 in combination with crimp connector 5202or directly against substrate without crimp connector 5202. Pinch clip5202 may apply force radially, axially, or in a suitable direction toprovide a biasing force on sensor 138 and conductive pathway.

FIG. 56 shows an implementation of sensor carrier 402 in which contacts406 and 408 are formed from foldable conductive clips 5300. Sensor 138may be inserted through openings 5302 in each clip 5300 and mechanicallysecured to substrate 404 and conductively coupled to clips 5300 by afolding a portion 5304 of each of clips 5300 over onto sensor 138.

Portions 5304 of clips 5300 may also form contacts 410 and 412 forcoupling to external equipment such as a manufacturing station (e.g., atesting station, a calibration station, an assembly station, a coatingstation, or other manufacturing stations). However, this is merelyillustrative. In other implementations, one or more electrode breakoutsthat are conductively coupled to clips 5300 may be provided to form, forexample, one or more of contacts 410 and 412 on substrate 404. Suchbreakouts may be formed on a surface of substrate 404 that is opposed tothe surface to which sensor 138 is attached, on the same surface assensor 138, or on an edge or sidewall of substrate 404 and coupled toclips 5300 by conductive vias or other conductive layers, structures, orinterconnects within or on substrate 404.

Clips 5300 also form datum features for positioning and aligning sensor138 relative to substrate 404. Substrate 404 may be sized and shaped (ormay include structural features) that form anchoring features forsubstrate 404 relative to manufacturing stations and/or a housing of awearable device. In this way, sensor carrier 402 may be used to easilyposition and align sensor 138 for both manufacturing and assemblyoperations (e.g., using the datum features to align the sensor relativeto substrate 404 and the anchoring features to align the substraterelative to the manufacturing or wearable equipment).

The conductive components of the sensor carrier 402 in the variousembodiments described herein are electrically isolated from each otherand the environment when installed in on-skin sensor assembly 600. Forexample, contacts 406, 408, 410, and 412 may be electrically isolatedfrom each other and the environment, using a non-conductive adhesivesuch as a one or two-part epoxy, using a polyurethane, using a lowpressure overmolding such as a moldable polyamide or a moldablepolyolefin, using an injection overmolded thermoplastic or thermoset,using a non-elastomer such as welded clamshell plastic, adhesivelybonded clamshell, single or 2-sided cavity potted with sealant, e.g.,epoxy, urethane, silicone, etc., or using a factory pre-compressedelastomer such as a constrained two-part cavity that holds an elastomerin a compressed state. The two-part cavity may hold the elastomer in thecompressed state by a snap fit, a bonding such as an ultrasonic weld, alaser weld, a solvent bond, or a heat stake, or a mechanical fastenersuch as a screw, rivet, clip, or other fastener.

Illustrative operations that may be performed for manufacturing andusing a pre-connected analyte sensor are shown in FIG. 57 .

At block 5400, an analyte sensor such as analyte sensor 138 may beprovided. As described herein the analyte sensor may have an elongatedbody (e.g., an elongated conductive body with an elongated conductivecore), and a working electrode on the elongated body (e.g., at a distalend of the elongated body). The analyte sensor may also include one ormore electrical contacts at a proximal end or elsewhere along theelongated body and coupled, respectively, to the working electrodeand/or the reference electrode.

At block 5402, a sensor carrier such as one of the implementations ofsensor carrier 402 described herein may be attached, for example, to theproximal end of the elongated body. Attaching the sensor carrierincludes coupling one or more contacts (e.g., on a substrate) of thesensor carrier to one or more corresponding electrical contacts on theelongated body.

At block 5403, a work station such as a manufacturing station isprovided. As described herein, a manufacturing station can be configuredto perform one or more dip coating processes to form the membrane 108described above on the working electrode.

At block 5404, the analyte sensor may be coupled to at least one testingstation (e.g., testing station 5002) by coupling the sensor carrier tocircuitry of the at least one test station. Coupling the sensor carrierto the circuitry of the at least one test station may includemechanically coupling one or more anchoring features such as a substrateof the sensor carrier to a mating interface of the test station suchthat one or more external contacts on the substrate are coupled to oneor more corresponding contacts at the test station. An identifier forthe sensor on the sensor carrier may be read by the testing station.Test data obtained by the test station may be stored and/or transmitted,in association with the identifier, by the test station.

At block 5406, the analyte sensor may be coupled to at least onecalibration station (e.g., calibration station 5004) by coupling thesensor carrier to circuitry of the at least one calibration station.Coupling the sensor carrier to the circuitry of the at least onecalibration station may include mechanically coupling the one or moreanchoring features such as the substrate of the sensor carrier to amating interface of the calibration station such that one or moreexternal contacts on the substrate is coupled to one or morecorresponding contacts at the calibration station. An identifier for thesensor on the sensor carrier may be read by the calibration station.Calibration data obtained by the calibration station may be storedand/or transmitted, in association with the identifier, by thecalibration station. Calibration data may be stored on the sensorcarrier or transmitted for later use by an on-skin sensor assembly 600during in vivo use of sensor 138.

Sensor carrier 402 may be coupled to one or more additionalmanufacturing stations as desired. The additional manufacturing stationsmay include potentiostat measurement stations, sensor straighteningstations, membrane dipping stations, curing stations, analytesensitivity measurement stations, and/or inspection stations.

At block 5408, the sensor carrier may be coupled to sensor electronics(e.g., sensor electronics 112 of electronics unit 500) of a wearabledevice such as on-skin sensor assembly 600. Coupling the sensor carrierto the sensor electronics may include coupling the one or more externalcontacts on the sensor carrier to corresponding contacts of the sensorelectronics. In some embodiments, coupling the sensor carrier to thesensor electronics may include securing the sensor carrier between abase such as base 128 and electronics unit 500 as described herein. Areader in the on-skin sensor assembly 600 may obtain an identifier ofthe sensor from the sensor carrier. Calibration data for the sensor maybe obtained based on the identifier.

At block 5410, in vivo signals from the working electrode (e.g., and areference electrode) may be obtained and processed with the sensorelectronics. The in vivo signals from the working electrode (e.g., and areference electrode) may be received by the sensor electronics from thesensor through the circuitry of the sensor carrier.

The methods disclosed herein comprise one or more steps or actions forachieving the described methods. The method steps and/or actions may beinterchanged with one another without departing from the scope of theclaims. In other words, unless a specific order of steps or actions isspecified, the order and/or use of specific steps and/or actions may bemodified without departing from the scope of the claims. For example,the operations described above in connection with blocks 5404 and 5406may be reversed and/or may be performed in parallel.

In some scenarios, it may be desirable to couple sensor 138 to one ormore contacts on a substrate in a preferred position and orientation.FIG. 58 shows an exemplary apparatus 5531 in which sensor 138 isoriented to substrate 5530 using an elastomeric tube. As shown in FIG.58 , apparatus 5531 may include a substrate 5530 having one or moreconductive contacts such as contacts 5532 and 5534 (e.g., exposed copperpads on a printed circuit substrate), and an elastomeric tube 5500.Elastomeric tube 5500 may be formed from a non-conductive elastomer.

As shown, elastomeric tube 5500 may be formed with a “D”, “O”, oval,pyramidal, or hemispherical shaped cross-section having an elongatedcutout 5503 in the bottom portion of the elastomeric tube 5500 withinwhich sensor 138 is disposed. In this way, sidewalls of the elongatedcutout of elastomeric tube 5500 can align sensor 138 relative tosubstrate 5530.

Bottom portions 5502 on either side of cutout 5503 may be attached tosubstrate 5530. The bottom portions 5502 may be attached to substrateusing adhesive 5504 such as a pressure-sensitive adhesive. The elongatedopening 5501 and cutout 5503 in the elastomeric tube 5500 providessufficient space that, in order to assemble the apparatus, tube 5500 canbe placed over sensor 138 while sensor 138 is in place on substrate5530.

FIG. 59 shows an exploded perspective view of the apparatus of FIG. 55in which contacts 5532 and 5534 can be seen on substrate 5530. Sensor138 may be positioned over one or more contacts such as contacts 5532and 5534.

Sensor 138 may be loosely held within opening 5501 of tube 5500 duringinitial placement of the tube over the sensor, and then be fixed to thesubstrate 5530 by the tube when the tube is compressed (e.g., by anupper housing of a wearable device). In this way, sensor 138 may becommunicatively coupled and mechanically fixed to a substrate withoutsoldering or other bonding operations.

During manufacturing operations and/or during in-vivo use of sensor 138,sensor 138 may be held in place on substrate 404 by external compressionof tube 5500. FIG. 60 shows an example in which sensor 138 is held inplace by compression of tube 5500 by a housing structure. For example,housing 5700 (e.g., a housing of a wearable device or a lid or clip fora manufacturing station) may include a protruding member 5702 that, inan assembled configuration, compresses tube 5500 to secure sensor 138.

As noted above in connection with, for example, FIGS. 35B, 43, 47A, 47B,50, and 51 , during manufacturing operations, multiple sensors 138 maybe carried by a common sensor carrier. However, in some scenarios, acommon carrier such as an intelligent carrier may be provided formanufacturing operations for multiple pre-connected sensors. FIG. 61shows an example of a carrier for multiple pre-connected sensors. Asshown in FIG. 58 , a carrier 5800 may include a housing 5802 withinterfaces 5804 for multiple pre-connected sensors. Housing 5802 may bea substantially solid substrate or may be a housing that forms aninterior cavity within which other components are mounted and/orconnected.

Each interface 5804 may be configured to receive a sensor carrier 402 inany of the implementations described herein. For example, each interface5804 may include one or more features that interface with one or morecorresponding anchoring features of a sensor carrier as described hereinin accordance with various implementations. Carrier 5800 may includecircuitry 5806 (e.g., one or more processors and/or memory) configuredto communicate with sensors 138 and/or external computing equipment.Circuitry 5806 may include communications circuitry such as one or moreantennas for transmitting and/or receiving data from external equipment.Housing 5802 may include one or more structures 5810 (e.g., clips,clasps, protrusions, recesses, notches, posts, or the like) formechanically coupling carrier 5800 to manufacturing equipment. One ormore conductive contacts 5808 may be provided on housing 5802 thatcommunicatively couple manufacturing equipment to sensors 138 throughthe carrier.

As shown, each interface 5804 may be associated with a particularidentification number (represented, as an example, in FIG. 58 as I₁, I₂. . . I_(N-1), and I_(N)). Circuitry 5806 may electronically identifysensors mounted in interfaces 5804 of carrier 5800 with theidentification number associated with that interface. However, this ismerely illustrative. In other implementations, sensors 138 may beuniquely identified by circuitry 5806 using a reader in each ofinterfaces 5804 that reads an identifier such as identifier 450 on thesensor carrier. Testing and/or calibration data may be gathered byprocessing circuitry 5806 and stored and/or transmitted along with anidentifier for each sensor.

During manufacturing, one or more pre-connected sensors may be loadedcarrier 5800. Carrier 5800 may secure the pre-connected sensors thereinand perform potentiostat measurements for each sensor (e.g., usingcircuitry 5806). Sensors 138 may be secured to interfaces 5804 byindividual mounting features or carrier 5800 may be provided with alocking mechanism such as a slidable bar 5812. Slidable bar 5812 may beslidable (e.g., by a handle 5814) between an open position as shown, inwhich sensor carriers can be inserted into and removed from interfaces5804, to a closed position in which bar 5812 blocks removal of thesensor carriers from the interfaces.

In some scenarios, an initial measurement test may be performed bycarrier 5800 to test the potentiostat connection through the sensorinterconnect electrodes and the sensor surfaces. Manufacturingoperations that may be performed for sensors 138 coupled to carrier 5800may include physical manipulation of the sensor such as straightening ofthe sensors. Carrier 5800 may facilitate more efficient manufacturing byallowing multiple sensors to be straightened in a single operation usingautomated straightening equipment.

Carrier 5800 may facilitate potentiostat and/or other measurements atvarious stages of manufacturing for sensors 138. Potentiostatmeasurements may be performed before, during, and/or after straighteningoperations and information regarding sensor damage or any othermechanical stress that might be introduced by the straightening may besaved and/or transmitted along with associated sensor ID's.

Manufacturing operations that may be performed for sensors 138 coupledto carrier 5800 may also include a membrane process in which dippingoperations are performed to form a membrane such as membrane 508 foreach sensor. Straightened sensors 138 mounted in carrier 5800 may beconcurrently dipped. Potentiostat measurements may be performed before,during, and/or after membrane operations and information associated withthe electrochemistry of the sensors and dipping process may be gathered,processed, stored, and/or transmitted by carrier 5800.

Manufacturing operations that may be performed for sensors 138 coupledto carrier 5800 may also include a curing process. Performing curing forgroups of sensors 138 mounted in carrier 5800 may allow the curingprocess to take less space, which can reduce the footprint of themanufacturing area used by curing equipment. Potentiostat measurementsmay be performed before, during, and/or after curing operations andinformation associated with the electrochemistry of the sensors andcuring process may be gathered, processed, stored, and/or transmitted bycarrier 5800.

Manufacturing operations that may be performed for sensors 138 coupledto carrier 5800 may also include calibration operations. Because carrier5800 can perform connection testing early in the manufacturing process,improved analyte/electrochemical calibration can be performed by carrier5800 itself and/or in cooperation with external manufacturing equipment.Calibration data may be gathered, processed, stored, and/or transmittedby carrier 5800.

Gathering calibration and/or testing data with carrier 5800 can savetime in connecting and disconnecting additional external equipment.Gathering calibration and/or testing data with carrier 5800,particularly when data is gathered and stored automatically inconnection with sensor ID's, can also reduce calibration/testing errorsbecause the data is gathered by the same equipment throughout variousprocesses.

Manufacturing operations that may be performed for sensors 138 coupledto carrier 5800 may also include analyte concentration measurements. Forexample, carrier 5800 may be moved by manufacturing equipment (e.g., arobotic arm) to expose the sensors 138 mounted in the carrier throughvarious analyte baths (e.g., glucose baths). Carrier 5800 may gatherelectrical potential measurements during the various bath exposures.Information associated with the electrical potential measurements duringthe various bath exposures may be gathered, processed, stored, and/ortransmitted by carrier 5800.

Manufacturing operations that may be performed for sensors 138 coupledto carrier 5800 may also include analyte sensitivity measurements.Sensitivity measurements that may be performed by carrier 5800 mayinclude baseline measurements that indicate the signal from each sensorwithout analyte exposure, slope measurements that indicate the signalchange for a given amount of an analyte, and/or noise measurements.These sensitivity measurements may be stored, and/or transmitted bycarrier 5800.

Manufacturing operations that may be performed for sensors 138 coupledto carrier 5800 may also include visual inspection operations (e.g., bya technician). Providing a group of pre-connected sensors, mounted incarrier 5800, that have already been through all of thetesting/calibration/manufacturing operations described above may allow amore efficient and/or more automated visual inspection and rejection(e.g., because the exact physical location of each sensor within carrier5800 is known). Sensors 138 that have exhibited unusual electrochemistryor mechanical stress during manufacturing operations can be flagged bycarrier 5800 (e.g., using a display, a visual indicator, or transmissionof flag information to an external device) for retesting or rejection.

The connections between the elements shown in some figures illustrateexemplary communication paths. Additional communication paths, eitherdirect or via an intermediary, may be included to further facilitate theexchange of information between the elements. The communication pathsmay be bi-directional communication paths allowing the elements toexchange information.

Various operations of methods described above may be performed by anysuitable means capable of performing the operations, such as varioushardware and/or software component(s), circuits, and/or module(s).Generally, any operations illustrated in the figures may be performed bycorresponding functional means capable of performing the operations.

The various illustrative logical blocks, modules and circuits describedin connection with the present disclosure (such as the blocks of FIG. 2) may be implemented or performed with a digital signal processor (DSP),an application specific integrated circuit (ASIC), a field programmablegate array signal (FPGA) or other programmable logic device (PLD),discrete gate or transistor logic, discrete hardware components or anycombination thereof designed to perform the functions described herein.A processor may be a microprocessor, but in the alternative, theprocessor may be any commercially available processor, controller,microcontroller or state machine. A processor may also be implemented asa combination of computing devices, e.g., a combination of a DSP and amicroprocessor, a plurality of microprocessors, one or moremicroprocessors in conjunction with a DSP core, or any other suchconfiguration.

In one or more aspects, various functions described may be implementedin hardware, software, firmware, or any combination thereof. Ifimplemented in software, the functions may be stored on or transmittedover as one or more instructions or code on a computer-readable medium.Computer-readable media includes both computer storage media andcommunication media including any medium that facilitates transfer of acomputer program from one place to another. A storage media may be anyavailable media that can be accessed by a computer. By way of example,and not limitation, such computer-readable media can comprise varioustypes of RAM, ROM, CD-ROM or other optical disk storage, magnetic diskstorage or other magnetic storage devices, or any other medium that canbe used to carry or store desired program code in the form ofinstructions or data structures and that can be accessed by a computer.Also, any connection is properly termed a computer-readable medium. Forexample, if the software is transmitted from a website, server, or otherremote source using a coaxial cable, fiber optic cable, twisted pair,digital subscriber line (DSL), or wireless technologies such asinfrared, radio, and microwave, then the coaxial cable, fiber opticcable, twisted pair, DSL, or wireless technologies such as infrared,radio, WiFi, Bluetooth®, RFID, NFC, and microwave are included in thedefinition of medium. Disk and disc, as used herein, includes compactdisc (CD), laser disc, optical disc, digital versatile disc (DVD),floppy disk and Blu-ray® disc where disks usually reproduce datamagnetically, while discs reproduce data optically with lasers. Thus, insome aspects a computer readable medium may comprise non-transitorycomputer readable medium (e.g., tangible media). In addition, in someaspects a computer readable medium may comprise transitory computerreadable medium (e.g., a signal). Combinations of the above should alsobe included within the scope of computer-readable media.

Certain aspects may comprise a computer program product for performingthe operations presented herein. For example, such a computer programproduct may comprise a computer readable medium having instructionsstored (and/or encoded) thereon, the instructions being executable byone or more processors to perform the operations described herein. Forcertain aspects, the computer program product may include packagingmaterial.

Software or instructions may also be transmitted over a transmissionmedium. For example, if the software is transmitted from a website,server, or other remote source using a coaxial cable, fiber optic cable,twisted pair, digital subscriber line (DSL), or wireless technologiessuch as infrared, radio, and microwave, then the coaxial cable, fiberoptic cable, twisted pair, DSL, or wireless technologies such asinfrared, radio, and microwave are included in the definition oftransmission medium.

Further, it should be appreciated that modules and/or other appropriatemeans for performing the methods and techniques described herein can bedownloaded and/or otherwise obtained by a user terminal and/or basestation as applicable. For example, such a device can be coupled to aserver to facilitate the transfer of means for performing the methodsdescribed herein. Alternatively, various methods described herein can beprovided via storage means (e.g., RAM, ROM, a physical storage mediumsuch as a compact disc (CD) or floppy disk, etc.), such that a userterminal and/or base station can obtain the various methods uponcoupling or providing the storage means to the device. Moreover, anyother suitable technique for providing the methods and techniquesdescribed herein to a device can be utilized.

It is to be understood that the claims are not limited to the preciseconfiguration and components illustrated above. Various modifications,changes and variations may be made in the arrangement, operation anddetails of the methods and apparatus described above without departingfrom the scope of the claims.

Unless otherwise defined, all terms (including technical and scientificterms) are to be given their ordinary and customary meaning to a personof ordinary skill in the art, and are not to be limited to a special orcustomized meaning unless expressly so defined herein. It should benoted that the use of particular terminology when describing certainfeatures or aspects of the disclosure should not be taken to imply thatthe terminology is being re-defined herein to be restricted to includeany specific characteristics of the features or aspects of thedisclosure with which that terminology is associated. Terms and phrasesused in this application, and variations thereof, especially in theappended claims, unless otherwise expressly stated, should be construedas open ended as opposed to limiting. As examples of the foregoing, theterm ‘including’ should be read to mean ‘including, without limitation,’‘including but not limited to,’ or the like; the term ‘comprising’ asused herein is synonymous with ‘including,’ ‘containing,’ or‘characterized by,’ and is inclusive or open-ended and does not excludeadditional, unrecited elements or method steps; the term ‘having’ shouldbe interpreted as ‘having at least;’ the term ‘includes’ should beinterpreted as ‘includes but is not limited to;’ the term ‘example’ isused to provide exemplary instances of the item in discussion, not anexhaustive or limiting list thereof; adjectives such as ‘known’,‘normal’, ‘standard’, and terms of similar meaning should not beconstrued as limiting the item described to a given time period or to anitem available as of a given time, but instead should be read toencompass known, normal, or standard technologies that may be availableor known now or at any time in the future; and use of terms like‘preferably,’ ‘preferred,’ ‘desired,’ or ‘desirable,’ and words ofsimilar meaning should not be understood as implying that certainfeatures are critical, essential, or even important to the structure orfunction of the invention, but instead as merely intended to highlightalternative or additional features that may or may not be utilized in aparticular embodiment of the invention. Likewise, a group of itemslinked with the conjunction ‘and’ should not be read as requiring thateach and every one of those items be present in the grouping, but rathershould be read as ‘and/or’ unless expressly stated otherwise. Similarly,a group of items linked with the conjunction ‘or’ should not be read asrequiring mutual exclusivity among that group, but rather should be readas ‘and/or’ unless expressly stated otherwise.

Where a range of values is provided, it is understood that the upper andlower limit and each intervening value between the upper and lower limitof the range is encompassed within the embodiments.

With respect to the use of substantially any plural and/or singularterms herein, those having skill in the art can translate from theplural to the singular and/or from the singular to the plural as isappropriate to the context and/or application. The varioussingular/plural permutations may be expressly set forth herein for sakeof clarity. The indefinite article “a” or “an” does not exclude aplurality. A single processor or other unit may fulfill the functions ofseveral items recited in the claims. The mere fact that certain measuresare recited in mutually different dependent claims does not indicatethat a combination of these measures cannot be used to advantage. Anyreference signs in the claims should not be construed as limiting thescope.

It will be further understood by those within the art that if a specificnumber of an introduced claim recitation is intended, such an intentwill be explicitly recited in the claim, and in the absence of suchrecitation no such intent is present. For example, as an aid tounderstanding, the following appended claims may contain usage of theintroductory phrases “at least one” and “one or more” to introduce claimrecitations. However, the use of such phrases should not be construed toimply that the introduction of a claim recitation by the indefinitearticles “a” or “an” limits any particular claim containing suchintroduced claim recitation to embodiments containing only one suchrecitation, even when the same claim includes the introductory phrases“one or more” or “at least one” and indefinite articles such as “a” or“an” (e.g., “a” and/or “an” should typically be interpreted to mean “atleast one” or “one or more”); the same holds true for the use ofdefinite articles used to introduce claim recitations. In addition, evenif a specific number of an introduced claim recitation is explicitlyrecited, those skilled in the art will recognize that such recitationshould typically be interpreted to mean at least the recited number(e.g., the bare recitation of “two recitations,” without othermodifiers, typically means at least two recitations, or two or morerecitations). Furthermore, in those instances where a conventionanalogous to “at least one of A, B, and C, etc.” is used, in generalsuch a construction is intended in the sense one having skill in the artwould understand the convention, e.g., as including any combination ofthe listed items, including single members (e.g., “a system having atleast one of A, B, and C” would include but not be limited to systemsthat have A alone, B alone, C alone, A and B together, A and C together,B and C together, and/or A, B, and C together, etc.). In those instanceswhere a convention analogous to “at least one of A, B, or C, etc.” isused, in general such a construction is intended in the sense one havingskill in the art would understand the convention (e.g., “a system havingat least one of A, B, or C” would include but not be limited to systemsthat have A alone, B alone, C alone, A and B together, A and C together,B and C together, and/or A, B, and C together, etc.). It will be furtherunderstood by those within the art that virtually any disjunctive wordand/or phrase presenting two or more alternative terms, whether in thedescription, claims, or drawings, should be understood to contemplatethe possibilities of including one of the terms, either of the terms, orboth terms. For example, the phrase “A or B” will be understood toinclude the possibilities of “A” or “B” or “A and B.”

All numbers expressing quantities of ingredients, reaction conditions,and so forth used in the specification are to be understood as beingmodified in all instances by the term ‘about.’ Accordingly, unlessindicated to the contrary, the numerical parameters set forth herein areapproximations that may vary depending upon the desired propertiessought to be obtained. At the very least, and not as an attempt to limitthe application of the doctrine of equivalents to the scope of anyclaims in any application claiming priority to the present application,each numerical parameter should be construed in light of the number ofsignificant digits and ordinary rounding approaches.

All references cited herein are incorporated herein by reference intheir entirety. To the extent publications and patents or patentapplications incorporated by reference contradict the disclosurecontained in the specification, the specification is intended tosupersede and/or take precedence over any such contradictory material.

Headings are included herein for reference and to aid in locatingvarious sections. These headings are not intended to limit the scope ofthe concepts described with respect thereto. Such concepts may haveapplicability throughout the entire specification.

Furthermore, although the foregoing has been described in some detail byway of illustrations and examples for purposes of clarity andunderstanding, it is apparent to those skilled in the art that certainchanges and modifications may be practiced. Therefore, the descriptionand examples should not be construed as limiting the scope of theinvention to the specific embodiments and examples described herein, butrather to also cover all modification and alternatives coming with thetrue scope and spirit of the invention.

Various system and methods described may be fully implemented and/orcontrolled in any number of computing devices. Typically, instructionsare laid out on computer readable media, generally non-transitory, andthese instructions are sufficient to allow a processor in the computingdevice to implement the method of the invention. The computer readablemedium may be a hard drive or solid state storage having instructionsthat, when run, are loaded into random access memory. Inputs to theapplication, e.g., from the plurality of users or from any one user, maybe by any number of appropriate computer input devices. For example,users may employ a keyboard, mouse, touchscreen, joystick, trackpad,other pointing device, or any other such computer input device to inputdata relevant to the calculations. Data may also be input by way of aninserted memory chip, hard drive, flash drives, flash memory, opticalmedia, magnetic media, or any other type of file—storing medium. Theoutputs may be delivered to a user by way of a video graphics card orintegrated graphics chipset coupled to a display that maybe seen by auser. Alternatively, a printer may be employed to output hard copies ofthe results. Given this teaching, any number of other tangible outputswill also be understood to be contemplated by the invention. Forexample, outputs may be stored on a memory chip, hard drive, flashdrives, flash memory, optical media, magnetic media, or any other typeof output. It should also be noted that the invention may be implementedon any number of different types of computing devices, e.g., personalcomputers, laptop computers, notebook computers, net book computers,handheld computers, personal digital assistants, mobile phones, smartphones, tablet computers, and also on devices specifically designed forthese purpose. In one implementation, a user of a smart phone orwi-fi—connected device downloads a copy of the application to theirdevice from a server using a wireless Internet connection. Anappropriate authentication procedure and secure transaction process mayprovide for payment to be made to the seller. The application maydownload over the mobile connection, or over the WiFi or other wirelessnetwork connection. The application may then be run by the user. Such anetworked system may provide a suitable computing environment for animplementation in which a plurality of users provide separate inputs tothe system and method. In the below system where factory calibrationschemes are contemplated, the plural inputs may allow plural users toinput relevant data at the same time.

What is claimed is:
 1. A wearable device for measuring an analyteconcentration in a host, the wearable device comprising: a housing; atranscutaneous analyte sensor comprising: an in-vivo portion configuredto be inserted in a living body of a host during a sensor session,wherein the in-vivo portion comprises an electrode, wherein theelectrode is configured to generate a signal indicative of an analyteconcentration; an ex-vivo portion configured to remain outside theliving body of the host during the sensor session; a first printedcircuit board substrate; a second printed circuit board substrate,wherein the second printed circuit board substrate is positionedadjacent to and substantially parallel with the first printed circuitboard substrate; sensor electronics configured to process the signalgenerated by the electrode, wherein the sensor electronics comprisesconductive components mounted to one or both of the first printedcircuit board substrate and the second printed circuit board substrate;and at least one opening in one or both of the first printed circuitboard substrate and the second printed circuit board substrate, whereinthe at least one opening is aligned with at least one of the conductivecomponents mounted on the other of the first printed circuit boardsubstrate or the second printed circuit board substrate.
 2. The wearabledevice of claim 1, wherein the at least one opening comprises at leastone through-hole.
 3. The wearable device of claim 2, comprising threethrough-holes.
 4. The wearable device of claim 2, wherein the at leastone through-hole is aligned directly over the at least one of theconductive components.
 5. The wearable device of claim 1, wherein theex-vivo portion of the transcutaneous analyte sensor is secured to thehousing with adhesive.
 6. The wearable device of claim 1, wherein theconductive components comprise traces.
 7. The wearable device of claim1, wherein the conductive components comprise a battery.
 8. The wearabledevice of claim 1, wherein the conductive components comprise apotentiostat.
 9. The wearable device of claim 1, wherein the conductivecomponents comprise a telemetry module.
 10. The wearable device of claim1, wherein the first printed circuit board substrate and the secondprinted circuit board substrate are connected by a foldable portion. 11.The wearable device of claim 10, wherein the foldable portion has awidth that is less than the first printed circuit board substrate andthe second printed circuit board substrate.
 12. The wearable device ofclaim 1, wherein the sensor electronics comprises both analog componentsand digital components.
 13. The wearable device of claim 12, wherein theat least one opening is aligned with an analog component of the sensorelectronics.
 14. The wearable device of claim 1, wherein the ex-vivoportion of the transcutaneous analyte sensor is electrically coupled tothe first printed circuit board substrate or the second printed circuitboard substrate.
 15. The wearable device of claim 14, wherein theex-vivo portion of the transcutaneous analyte sensor is electricallycoupled to the first printed circuit board substrate or the secondprinted circuit board substrate with clips.
 16. The wearable device ofclaim 1, wherein the first or second printed circuit board substratecomprises interface circuitry configured to connect to traces on a testpanel circuit board during manufacture.
 17. A method of making awearable device for measuring an analyte concentration in a host, thewearable device comprising a housing, a transcutaneous analyte sensor,and sensor electronics configured to process a signal generated by thetranscutaneous analyte sensor, the method comprising: mountingconductive components of the sensor electronics to one or both of afirst printed circuit board substrate and a second printed circuit boardsubstrate; electrically coupling an ex-vivo portion of thetranscutaneous analyte sensor to the first printed circuit boardsubstrate or the second printed circuit board substrate; positioning thefirst and second printed circuit board substrates adjacent to andsubstantially parallel with each other; and aligning openings in thefirst printed circuit board substrate or the second printed circuitboard substrate with conductive components of the sensor electronicsmounted on the other one of the first printed circuit board substrate orthe second printed circuit board substrate.
 18. The method of claim 17,comprising electrically coupling the ex-vivo portion of thetranscutaneous analyte sensor to the first printed circuit boardsubstrate or the second printed circuit board substrate with clips. 19.The method of claim 17, comprising aligning at least one through holewith an analog component of the sensor electronics.
 20. The method ofclaim 17, comprising securing the ex-vivo portion of the transcutaneousanalyte sensor to the housing with adhesive.
 21. The method of claim 17,wherein the conductive components comprise traces.
 22. The method ofclaim 17, wherein the conductive components comprise a battery.
 23. Themethod of claim 17, wherein the conductive components comprise apotentiostat.
 24. The method of claim 17, wherein the conductivecomponents comprise a telemetry module.
 25. The method of claim 17,comprising singulating at least one of the first printed circuit boardsubstrate and the second printed circuit board substrate from an arrayof other substrates.